Not finding the right medicine? We can help
Yes, Repatha is available in !*
*and if it isn’t, we’ll make it available specifically for you.
Repatha (evolocumab)
This medicine requires a prescription. See “Prescription Guide”.
We can only help if the medicine is not available in your country. Learn more.
Repatha (evolocumab) is a medication used with other medicines to treat people with high blood cholesterol levels (hypercholesterolemia) and cardiovascular disease.
Disease Indications
Risk of cardiovascular events, Hypercholesterolemia
Manufacturer
Amgen Inc.
Usage
Subcutaneous
Medicine approved by
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European Medical Agency (EMA)
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Food and Drug Administration (FDA)
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Health Canada
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Pharmaceuticals and Medical Devices Agency (PMDA)
Why trust us?
- We’re the only specialized global platform helping patients get treatments unavailable in their countries.
- We’re experts in medicine import regulations. We also know the rules in your country.
- 11,000+ patients worldwide have already trusted us with their lives.
- We’re rated 4.8/5 on Trustpilot and 4.8/5 on Google, by patients like you.
FREQUENTLY ASKED QUESTIONS
We help you access approved medicines that are not approved or available in your country of residence.
Legal
Is my personal information confidential?
Yes, everyone.org agrees to preserve the confidentiality of all customer and patient information and to not divulge this information in any form, except when authorised by the patient or required by law.
Where can I verify everyone.org's registration with the Dutch Ministry of Health?
everyone.org is registered with the Dutch Ministry of Health (registration number 16258 G) as a pharmaceutical wholesaler. Our license can be found here. We are GDP-certified, and are regularly audited by the authorities in the Netherlands. Learn how you can verify our credentials here.
Is everyone.org 100% safe and secure?
Yes. everyone.org is registered with the Dutch Ministry of Health as a pharmaceutical wholesaler (registration number 16258 G). We always follow your country’s laws and regulations, and discuss the legal requirements with you. We only ship medicines when our patients have a prescription from their treating doctor.
What documents will I need to import a medicine?
You always need a prescription from a doctor based in your country. Other documents, such as an import license from the Ministry of Health, may be needed and depend on your country’s regulations. Contact usand we will provide you all the information about the required documents for your country.
Is it legal to import medicines from abroad?
Yes. Most countries have a Named Patient or Personal Import law or regulation which enables patients to import medicines from abroad that have not yet been approved in the patient’s country. This can only be done with a doctor's prescription and, depending on the country, some additional requirements. For more information, read our blog post here.
Finances
Payment
Why do I need to pay before receiving the medicine?
As we operate on the Named Patient Import basis, every order is specifically processed for an individual patient for his/her personal use (only). Legally, neither we nor the supplier are allowed to hold stock of those medicines, instead we are obliged to source it on a case by case basis. We need to pay before we get the medicines, therefore we can only process your order after we receive your payment.
How can I be sure that I will receive the medicine?
We are a licensed company and have safely and legally delivered more than 10,000 medicines to 175 countries and territories worldwide. You can read our patient reviews on Google, Facebook, and Trustpilot, and we also have some of our Patient Stories on our blog. You can speak to us on the phone and personally visit our office. When you place an order with us, you will be informed of every step in the process. Our team will keep you personally updated about your order until the moment it's in your hands.
How do I pay for the medicine?
After you place an order with us, you will receive an order confirmation with the payment details. Please make sure that you make the payment for the amount stated on the invoice in Euros (€). We accept bank transfers and online credit card payments (a 3.6% fee applies for credit card payments).
After I have received the order confirmation, how long is the quoted price valid for?
The price quoted on your order confirmation is valid for three days from the send date. If you do not pay within the three-day time frame, the prices may be subject to change. If you need more time, please let us know.
What payment methods do you offer?
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 3.6% fee applies when paying by credit card.
Can I pay in cash?
No. We only accept payments made by credit card or bank transfer. Payments are fully encrypted and secure.
Do I have to pay in Euros?
Yes. At this time we can only accept payment in Euros.
Will I receive proof of payment?
Yes, as soon as we see the payment is received in our bank account, you will receive a payment confirmation in the form of an invoice. This is also the confirmation that your order has been processed.
Can I pay when I pick up the medicines?
No. We can only process your order and source your medicine after having received your full payment. Paying in the pharmacy during pick-up is currently not an option.
Why do I need to pay bank charges?
Your bank might calculate costs for the conversion of your currency to Euros. Please make sure you transfer the full amount of our fee as mentioned on our invoice and do not deduct the bank’s service charges.
Do I need to pay import taxes?
Depending on your country, import taxes might apply to shipping medicines. Import taxes normally consist of import VAT and a fee that customs may charge. Since these are different per country (in some countries, the import taxes might even be exempt for pharmaceuticals) and per customs office we often cannot calculate them in advance. Import taxes must be paid by the receiver. They are not included in our invoice. You can contact your local customs office to find out if they apply import taxes and how they can be paid.
Am I eligible for a VAT refund?
Yes, we can help you obtain a VAT refund if you collect your order from our partner pharmacy in the Netherlands or Luxembourg and meet the following requirements. To be eligible, you must:
- Have permanent residence outside the European Union;
- Travel with a non-EU passport or valid proof of non-EU residence;
- Have a flight ticket or travel document showing that you are leaving the EU;
- Take the medicines with you, unused, outside the EU within 90 days after purchase;
- Present the medicines, your receipt, passport, and travel document to customs when leaving the EU;
- Obtain customs confirmation that the goods are being exported from the EU.
We will provide you with the full original receipt needed for the VAT refund process.
If you collect your order in the Netherlands:*You must go to customs when leaving the EU and present the required documents and medicines. The customs approval is then processed digitally through the Dutch customs system. You do not need to obtain a physical stamp, but you must still complete the customs approval step.
If you collect your order in Luxembourg:*You must go to customs when leaving the EU and obtain a physical customs stamp on the required documents. This stamp is needed as proof that the goods have been exported from the EU.
Our Patient Support team will provide further information and guidance during the order process.
Unfortunately, we are unable to help with VAT refunds following delivery, or collection from partner pharmacies outside the Netherlands or Luxembourg.
Do I need to pay VAT in The Netherlands?
You need to pay Dutch VAT in two situations:
- If you are residing within the European Union and you are not a company
- If you are coming to Amsterdam to pick up your order
In case of pick up, you may be eligible for a VAT tax refund if you live outside the European Union.
How much VAT do I have to pay in The Netherlands?
If Dutch VAT applies, you will need to pay 9% on the medicine and 9% on services, such as on the Named Patient fee, shipping costs and pharmacy fee.
Price
How can I see how much a medicine costs?
The price of every medicine is listed on our website. Very recently approved medicines may not have a price yet on our website - in that case, you can contact our team for more information. Our Named Patient handling fee, shipping costs and any tax (if applicable) are not included in the product prices unless stated otherwise. Contact us and we will compile a quote which includes all of these costs and send that to you.
Why are the prices of the medicines so high?
The price is determined by the manufacturer and can vary from one market to another. Often, the first market where a novel medicine is approved is the USA. Unfortunately, it’s also the most expensive pharma market in the world. Until another regulator elsewhere approves the medicine, it’s only available at the US price. Over time, as more regulators approve the medicine and the production levels go up, the price may change, but most of our patients don't have the time to wait. Therefore we offer the medicines as soon as possible, from the supplier with the lowest price.nContact your health insurer for potential reimbursement, which varies from country to country.
Can I get a quote online?
No. Please contact us to receive a detailed quote. If you have questions about the medicine, such as strength, dosage, price, or any questions about our service, do not hesitate to ask.
How is the cost of each medicine determined?
The base cost of each medicine is set by the manufacturer. On top of that, we add a fee to cover the cost of our services, enabling us to continue functioning as a social enterprise. Profits will be reinvested into maintaining our high level of service, and expanding our medicines portfolio and partner network globally. We strive to cut out as many middle men as possible and always aim for the best price possible.
Reimbursement
Can I claim the cost of the medicine via my country's healthcare system?
Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Will my health insurance cover the treatment?
In some cases, health insurance companies may partially or fully cover the cost of the medicine. We recommend checking this directly with your health insurance company.
What information should I provide to my health insurance company?
Each health insurance company has their own procedures for submitting a request or claim. However, as a starting point, we recommend writing a letter to them outlining the following:
- That you want to import an approved medicine from abroad
- The lack of reasonable treatment options available in your country (if you can, include a letter from a doctor confirming this).
- That the medicine has already been approved in another country (state the name of the country)
- That your treating doctor states that this medicine is the best option for you (include a copy of the prescription in the letter to the healthcare insurance company)
What is crowdfunding?
Crowdfunding is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveFoward, FundRazr and Watsi. You also may find these tips on getting started with medical crowdfunding helpful.
Ordering and shipping
Ordering
How can I order my medicines?
Contact us and provide us with the following information:
- Name of the patient
- Contact details of patient(email and phone number)
- Copy of patient’s ID
- Contact details of the Doctor (name, address, email and phone number)
- Shipping address
- Copy of the doctor's prescription
Shipping: We can deliver to the patient's residence, a pharmacy, or doctor's office / hospital, but this depends on the country. If you’re not sure what the right choice is for you, please get in touch with our Patient Support Team and we can help you work out your exact requirements.
Once we have received this information, one of our Patient Support Team members will then check your prescription and contact you to follow up on your order. Please note that other documents may be needed for import, we will guide you through the ordering process.
Do you accept insurance?
Generally not, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you.
Why do I need a prescription?
It is important that your treating doctor is fully aware and supports your treatment. Your doctor needs to monitor the treatment for safety reasons. The prescription is the evidence that your treating doctor supports you. It is also legally required by customs for import, and for collection from the pharmacy.
As part of our protocols we might reach out to your treating doctor for verification or information updates. By sending us your prescription you allow us to do so.
What information should the prescription contain?
The prescription should include:
- Patient's name and date of birth
- Name of the medicine and dosage
- Required quantity
- Doctor's name and signature
- Doctor's registration number and/or stamp
Ideally, the prescription should be issued in English. Alternatively, a translation (unofficial is sufficient) must be provided.
Please be aware that your doctor may be contacted by one of our team members or by the processing pharmacy in order to verify the prescription.
How far in advance should I place a new order?
The ordering procedure can take up to 3 weeks. In addition, you may need to apply for a new license or get a new prescription from your doctor. We advise you to contact us as early as possible to make sure your documents are valid. This is the only way that you can ensure that your treatment commences on time.
Can I cancel my order if I change my mind?
If you would like to cancel your order, please get in touch with our Patient Support team immediately. Generally, if you have already paid the invoice, the order has been processed by us and cannot be cancelled. We start sourcing the medicines as soon as we receive payment, and once the medicine has been ordered on behalf of the patient we cannot return the medicines. However, in some cases, there may be a delay in the sourcing process in which case we will have a small window for cancellations.
What happens if the payment is made after 3 days and the costs have changed?
As stated, the price quoted on your order confirmation is valid for three days from the send date. If you pay after this date and the prices have changed, you will be required to pay the price difference.
If I want to place another order, do I need a new prescription or a new import license?
This depends on the situation. In some cases the prescription is only valid for one order, while in others it can be used multiple times. This is only the case if it is a repeat prescription. In the case of import licenses, they vary from country to country, but they usually have an expiration date and a maximum number of medicine units that can be imported. Please confirm with a member of our Patient Support Team when you place a new order.
Can I order as a company?
Yes. To place an order with us as a company, you need to provide us the company's license to import medicines from abroad.
Shipping
How does the shipping process work?
Once we have sourced your medicines, we can ship them to you. During the shipping process, your parcel is exported from its original country and imported into your country. We include all the necessary documents in the package. Different countries have different regulations for importing medicines, and we ensure that the documentation relevant for your country is included. When it comes to the actual import, we use our international knowledge, connections and experience in importing and sending prescription medication to process your order.
How long does it take to ship my medicines?
Delivery times vary from country to country and are also dependent on the medicines you order, and on custom clearance, but a rough guide would be 1-2 weeks. Once the medicines have been shipped, we will send you a tracking number and keep you informed about your delivery. For a more detailed estimate for your desired medicine, please get in touch with our Patient Support Team.
How can I track my order?
When your order is shipped to you, you will receive a tracking number and a link to track your shipment online. This will allow you to be able to track your order. Our team will also stay close with regular personal updates until you have your medicine in your hands.
How will my order be shipped?
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers.
What is a cold chain shipment?
Some medicines need to be stored between 2 and 8 degrees Celsius. These are called “temperature controlled medicines”. This means that their shipment needs to be via an unbroken cold chain. When delivering these medicines, we ensure the medicines are packed properly, in a special transport box which regulates the temperature for sufficient time to arrive safely at the destination.
Will I be contacted when my order is on its way?
You may be contacted by our courier partners before your order is delivered, for example to inform you about the delivery time. Your contact details are always included on the parcel.
Can I pick up my medicines?
For EMA-approved medicines with prescriptions from within the Schengen zone, you can pick the medicines up from our partner pharmacy in Amsterdam, Luxembourg or Dusseldorf. For non-EMA approved medicines, with prescriptions from within the Schengen zone, you can pick the medicines up in our partner pharmacy in Dusseldorf. If you have requested to collect your medicines, you will receive a notification when the medicines are in the pharmacy and ready for you.
There are also options to deliver the medicines to other countries. Please get in touch with our Patient Support Team to discuss which other pick-up and delivery options may be suitable for you.
Can someone else pick up the medicines on my behalf?
Yes. You can authorise anyone to pick up the medicines on your behalf. In that case, you need to provide us the following documents:
- Copy of the ID/passport of the patient
- Copy of the ID/passport of the person who is coming to pick up the medicines
- Letter signed by the patient stating that he/she authorises this person to pick up the medicines on his/her behalf
Where is the pharmacy in Amsterdam located?
The Amsterdam pharmacy is located in Amsterdam Central Station, approximately 15 minutes from Schiphol Airport by train. You will receive the full pharmacy details when the medicines are ready for you. We will be happy to help you with advice for your stay in Amsterdam should you need it.
If I pick up my medicines, how will I take them home?
We will help package the medicines for travel. Please make sure you have the ability to take the medicines home safely. If the medicines require special transport conditions we will inform you in advance.
What if I pick up a medicine that needs to be transported in a temperature controlled way?
We will ensure the medicines are packed properly, in a special transportation box (at additional cost) that regulates the temperature for sufficient time. We will inform and instruct you on how to get your medicines home with the right temperature.
Can I take the medicines in my hand luggage?
Yes. We recommend you always keep the medicines with you in your hand luggage. We will provide a letter for your airline company stating that the medicine is for personal use and as it is delicate it needs to be transported carefully in the hand luggage (carry on luggage). We recommend that you contact the airline in advance to inform them.
How big will the parcel of medicines be?
The size of the parcel depends on the medicine and the number of boxes that you order. If you are collecting the medicines, we can inform you about the size of the parcel as soon as the parcel is ready to be picked up.
What happens if my medicines are held by customs?
Don’t worry, our team will be available to help you every step of the way to get the medicines released. There can be three steps to the clearings process:
- Step 1 - Customs may need to check the package to verify its contents. In order to streamline this step, we include a letter for customs with information about the contents. Any additional questions will be answered by everyone.org as and when we are contacted by customs.
- Step 2 - In some countries, there are additional questions from the medical regulatory agencies (i.e. the FDA, EMA, etc). We provide them with all the necessary information based on the information provided by the patient, such as: the prescription, copy of ID and a letter from the treating doctor to show that the medicines are for personal use.
- Step 3 - Customs fees. In some cases, the recipient will be requested to pay taxes and duties. These should be arranged by the patient or receiver and are not covered by everyone.org unless stated otherwise.
Please be aware that the import of the medicines always requires customs clearance and active cooperation from the importing party. We will help and guide you but are dependent on your cooperation and responsiveness.
About us
How can I contact you?
There are a few ways you can reach us:
- Complete the enquiry form on our Contact Us page
- Send an email: support@everyone.org
- Call us on:
- +31 20 808 4414 (EU)
- +1 646 381 0675 (US)
- +61 28 417 2910 (AUS)
Who is the everyone.org team?
Our team is made up of legal, logistical and patient support experts ready to help you access the latest approved medicines. Click here to meet the team.
Which languages do you speak?
Our operational language is English. However, we also speak: German, Dutch, Bulgarian, Romanian, Spanish, Italian, Portuguese, Bahasa Indonesia, Turkish, Hindi, Persian, and Malayalam.
What type of medicines do you have in your offering?
At the moment, our main focus is on oncological, neurological and rare diseases. However, if you are looking for a medicine which is not currently in our offering, please get in touch and we’ll do our best to help.
Can you provide medical advice?
No. Only your treating doctor can provide medical advice specific to your case. We highly value the doctor-patient relationship; our role is to support access to a medicine when requested by both patient and doctor.
Where are you located and what are your contact hours?
We are based in Amsterdam and our office hours are from 09.00 to 18.00 CET from Monday to Friday.
Why were you founded?
everyone.org was started after three of our founders lost family members and friends to Cancer and ALS, and the fourth one was diagnosed with ALS himself. This made them realise how important it is to have access to the best, and newest medicines, regardless of their location. Click here to read more about us.
Others
Available medicines
Can you help me import a medicine that is already approved in my country?
Our service can only help you import medicines that are either not approved or not available in your country. Sometimes, a medicine is approved but not (yet) available. In those cases we can help you access the medicines. But when a medicine is available in your country, we cannot supply it. If the medicine you are looking for is not available, please get in touch with our Patient Support Team to discuss further.
If a medicine is approved and available in my country, what are my next steps?
In this case, we cannot help you access the medicines, as you should be able to find it via regular, local channels. Your next step would be to talk with the doctor in your country and get a prescription. If you already have a prescription, then a pharmacy or hospital pharmacy will be able to help you find the medicine.
What if the medicines cost more in my country than what it says on your website?
Unfortunately, we are not allowed to provide medicines to people who already have access to them, even if the price is different. The prices are determined by pharmaceutical companies and government agencies, and are beyond our control.
What if the medicine I’m looking for isn’t on your website?
Please contact us. If your doctor has recommended a specific medicine and it's been approved somewhere in the world, we'll usually be able to find it for you.
How long does the process of finding new medicines take?
That depends on the medicine and how new it is. The process of identifying a reliable medicine source is generally completed within a couple of days, but in exceptional cases, or when a medicine has just been approved, it can take up to two weeks. If you wish to place an order, delivery can take another 1-2 weeks, but we will keep you informed on the estimated delivery date.
Medicine approval
How does the process of approving medicines work?
The development of new medicines involves a lot of research and clinical studies. After the studies have been concluded and the results are promising, the manufacturer can apply for approval in order to introduce the medicine to the public. The manufacturer decides which country they file the approval in.
The respective national and regional agencies, such as the Food and Drugs Administration (FDA) in the USA or the European Medical Authority (EMA) for the European Union assess these applications and make a decision on whether to approve new medicines. The review process is based on evaluation of the evidence provided by the company. Every agency uses a slightly different process.
How long does the approval process take?
The approval process can take over a year, depending on which national agency is reviewing the medicine. Even if one national agency approves a medicine, there is unfortunately no guarantee that another agency will ever approve the same medicine. Even after approval, it can still take time before the medicines are available in a country. We are able to help patients to access medicines up until the medicine is available in their country.
If the medicine that I need is not yet approved anywhere, are there any alternative medicines for me?
There may be another treatment option which is already approved and available in your country. We advise you to consult with your doctor in order to assess alternatives.
What is a clinical trial?
A clinical trial is a study designed to determine whether a new medicine is safe and effective. There are 4 phases within a clinical trial:
- Phase I - performed in a small number of healthy volunteers or very sick patients with lack of treatment options, designed to study the effects of the medicine in the human body.
- Phase II - larger number of patients, designed to evaluate the safety and efficacy of the medicine and to determine if different dosages of the treatment have different effects.
- Phase III - large number of patient groups, designed to confirm the safety and efficacy of the medicine.
- Phase IV - after the medicine has received regulatory approval, designed to evaluate the long-term effects.
How can I access a clinical trial?
Sometimes patients are able to access the medicine they're seeking through a clinical trial. Patients can check for clinical trials at ClinicalTrials.gov or Antidote.me. Unfortunately, the requirements for taking part in a clinical trial are often very strict. Statistics show that approximately 37% of patients fail the screening process.
What are the advantages and disadvantages of accessing a clinical trial?
An advantage of accessing a clinical trial is that the medicine is free of charge – pharmaceutical companies are not allowed to charge participants. A disadvantage is that many trials are 'placebo-controlled', which means that there is a chance that the participant does not receive the medicine but a placebo.
Updates
Do you have a newsletter?
At this time, we don't have a newsletter. However, we plan to have one in the current year. If you wish to receive any updates, send us an email and we will keep you informed.
How can I receive updates regarding the products that are coming soon?
Some products, although approved, are not yet available to purchase via everyone.org. If you are interested in staying informed about a specific medicine, please contact us and we will update you as soon as we are able to source it and offer it for purchase.
Repatha (evolocumab)
Package
Pre-filled syringe/pen or cartridge
Where can we deliver?
We have delivered medicines to more than 90 countries. Check if we have sent medicines to yours.
We currently can’t ship medicines to - contact us for alternative options.
Make an enquiry to receive information about the different options of obtaining for a patient in .
We haven’t shipped medicines to yet. You can count on us to make it happen.
Make an enquiry to receive information about the cost, shipping time and import details for .
Yes, we have successfully delivered medicines to .
Make an enquiry to receive information about the cost, shipping time and import details for .
PICK-UP IN PERSON FROM A PARTNER PHARMACY
We can arrange for you to pick up this medicine from our partner pharmacy in Luxembourg. Read more.
Pick-up from Luxembourg.
Depending on your particular circumstance, this option can be cheaper and require less paperwork than direct delivery. You can ask someone else to pick up the medicine on your behalf.
In some cases, medicines can be picked up from partner pharmacies in Amsterdam (the Netherlands) or Dusseldorf (Germany).
Tell our Patient Support Team if you’re interested in pick-up options for your order.
Pay safely using:
GDP compliant. View certificate.
Licensed wholesale distributor. View certificate.
What is Repatha (evolocumab) for?
Repatha (evolocumab) is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody for lowering levels of fats in the blood. It is indicated to treat:1
- adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of heart surgery.
- adults with high blood cholesterol levels called primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low density lipoprotein (LDL) or bad cholesterol. It is used along with diet alone or together with other cholesterol-lowering medicines.
- people with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH), who need additional lowering of LDL cholesterol. It is used along with other LDL-lowering medicines.
It is not known if this medicine is safe and effective in children with HoFH below 13 years of age or in children who do not have HoFH.1
It is available as a solution for injection in pre-filled syringes (140 mg), pre-filled pens (140 mg) and cartridges (420 mg). The cartridges are used together with an automated dosing device called a mini-doser.1
How does Repatha (evolocumab) work?
Evolocumab, the active substance in Repatha, is a monoclonal antibody (a type of protein) that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 can bind to cholesterol receptors that are found on the surface of liver cells. This permits these receptors to be broken down inside the cells and allows them to recycle back to the liver cell surface.
By doing so, Repatha can increase the number of receptors on the cell surface. As a result, the receptors can attach to LDL (“bad”)-cholesterol and remove it from the bloodstream. This helps lower blood cholesterol levels.
In patients with mixed dyslipidaemia, Repatha can help to lower other fatty substances from blood.
Where has Repatha (evolocumab) been approved?
Repatha (evolocumab) was approved by:
- The Food and Drug Administration (FDA), USA:
- on August 27, 2015 to treat adults with HeFH, HoFH, or cardiovascular disease.
- on December 1, 2017 to prevent heart attack and stroke.
- The European Medicines Agency (EMA):
- on July 17, 2015 to treat adults with HeFH, HoFH, or cardiovascular disease.
- Health Canada:
- on September 15, 2015 to treat adults with HeFH, HoFH, or cardiovascular disease.
- on June 19, 2018 to prevent heart attack and stroke.
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan:
- on January 21, 2016 to treat adults with HeFH, HoFH, or cardiovascular disease.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Repatha (evolocumab) taken?
The standard dosage is:1
- 140 mg every two weeks, or
- 420 mg (3 pre-filled syringes or 1 cartridge) once a month.
- 420 mg once a month.
- After 12 weeks, your treating doctor may decide to increase the dose to 420 mg every two weeks.
Inject the medicine of a prefilled pen or syringe under the skin (subcutaneous) into the thigh, upper arm, or stomach (abdomen).1
It it used in combination with standard of care treatment.1
Complete information about Repatha (evolocumab) dosage (modifications) and administration can be found in the official prescribing information listed in our references section.1
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Repatha (evolocumab)?
Common adverse reactions
The most common side effects ( ≥5% of patients) listed in the prescribing information include:1
- Runny nose
- Sore throat
- Symptoms of the common cold, flu or flu-like symptoms
- Back pain
- High blood sugar levels (diabetes)
- Redness, pain, or bruising at the injection site.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- Serious allergic reactions
Use in a specific population
It is not known whether Repatha (evolocumab) can harm a fetus. Tell your doctor if you get pregnant during treatment.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.1
References
1. Full prescribing information [FDA]: Repatha (evolocumab) [PDF]
Amgen, Aug 2015
2. Repatha
EMA.com, cited Aug 2021
Hypercholesterolemia and mixed dyslipidemia
The Food and Drug Administration (FDA) approval of Repatha (evolocumab) for treatment of adults with hypercholesterolemia and mixed dyslipidemia was based on the data of nine studies.1
This involved one 52-week placebo-controlled trial and eight 12-week placebo-controlled trials were performed. The studies involved 7,400 adult patients, including patients with heterozygous familial disease (HeFH) and homozygous familial disease (HoFH).2,3
Some of the studies looked at Repatha taken alone, and in other studies Repatha was taken in combination with other lipid-lowering medicines. Some studies compared Repatha with placebo and others to another medicine (ezetimibe).2,3
In 2 main, Repatha was given to a total of 155 patients with HoFH, which included 14 children older than 12 years.2,3
Results
The main efficacy outcome of the studies was the reduction in blood LDL-cholesterol levels.2,3
The studies found that people taking Repatha had a significant reduction in blood levels of LDL-cholesterol: people taking Repatha had an average reduction in LDL cholesterol of approximately 60% to 70%, more than placebo, and of around 40% more than ezetimibe.2,3
One of the studies in HoFH patients showed that Repatha taken together with other lipid-lowering medicines reduced fat levels in the blood, which is 15% to 32% more than placebo. The second study showed that during 28 weeks of treatment, Repatha was still able to reduce fat levels in the blood in these patients.2,3
Atherosclerotic heart disease and stroke
The Food and Drug Administration (FDA) approval of Repatha (evolocumab) for treatment of adults with atherosclerotic heart disease was based on data from study FOURIER (NCT01764633).4
FOURIER was a randomized, double-blind, placebo-controlled, multinational clinical trial that involved more than 27,500 patients with a history of established cardiovascular disease.Patients received either Repatha or placebo, both optimized statin therapy, for over 2 years on average.5
Results
The main efficacy outcome of the study was the number of cardiovascular events (meaning death, heart attack, stroke, hospitalization or surgery due to problems with the blood flow to the heart).5
People taking Repatha experienced a reduction in the risk of heart attack (27%), stroke (21%) and coronary revascularization (22%).4
In people taking Repatha, less than 10% had a cardiovascular event during the study compared to just over 11% of the people taking placebo.4
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Repatha (evolocumab) for the approved indication.2
References
1. FDA Approves Repatha (evolocumab) to Treat Certain Patients with High Cholesterol
Drugs.com, Aug 2015
2. Full prescribing information [FDA]: Repatha (evolocumab) [PDF]
Amgen, Aug 2015
3. Repatha
EMA.com, cited Aug 2021
4. FDA Approves Amgen's Repatha® (evolocumab) To Prevent Heart Attack And Stroke
Amgen.com, Dec 2017
5. Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
FOURIER study, cited Aug 2021
Repatha (evolocumab) treatment costs
The cost of your treatment with Repatha (evolocumab) depends on your prescription—factors like dosage, strength, and treatment duration come into play.
Our Patient Support team will help you calculate the total price in your case. To get started, submit a request for the medicine you need, and upload your prescription.
Repatha (evolocumab) Price and additional costs
The prices you see on our website reflect the lowest price at which we can access each medicine, plus a small markup that helps sustain our mission of expanding patient access.
We source from trusted suppliers at the best possible prices, but never at the expense of quality or safety.
Our Global Access Assistance Fee
For each order, we apply a Global Access Assistance fee. This fee covers our expenses related to medicine sourcing, logistics planning and follow-up, making sure we can offer you the highest standard of service from beginning to delivery. The fee is tiered according to the price of the medicine.
Shipping costs
Shipping costs depend on the type of shipping required (regular or cold chain) and the destination country. Fees may cover transport from our supplier to our partner pharmacy and final delivery to you.
Some medicines require special packaging (cool boxes, ice packs, data loggers) or transport insurance to ensure safe delivery. We’ll always provide a transparent cost breakdown before you place your order.
You can read a detailed overview of prices and costs here.
Payment methods when you buy Repatha (evolocumab)
When you buy Repatha (evolocumab), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 3.25% fee applies when paying by credit card.
Repatha (evolocumab) reimbursement
Depending on your country, you may be able to claim reimbursement for Repatha (evolocumab) through public healthcare or government support programs for medical treatment abroad. We recommend checking with your health ministry, local patient organizations, and support communities for guidance.
Medical insurance
While we don’t work directly with insurers, we provide a detailed invoice after payment, which you can submit for potential reimbursement.
Crowdfunding
Crowdfunding can help cover treatment costs by pooling donations from friends, family, and the wider community. Platforms like GoFundMe, FundRazr, and Watsi offer ways to seek support.
The Everyone.org Foundation
We know the financial burden of accessing new medicines can be overwhelming. That’s why we created the Everyone.org Foundation—raising funds to support vulnerable patients worldwide. Though still in its early stages, you can check with our Patient Support team about available funding options.
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping. For more details, please see our article on cold chain delivery.
Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping and shortages in availability.
Your order will be shipped via DHL, UPS, or specialized cold chain couriers. If you prefer a specific courier, let us know when placing your order.
Shipping costs depend on the medicine type and destination and may include special packaging (e.g., cool boxes, ice packs) or transport insurance. You'll receive a detailed cost breakdown when you inquire.
Standard delivery takes 5–10 working days, but your Patient Support agent will confirm the exact timeframe.
Prefer to pick up your medicine? You can collect it from our partner pharmacies in Amsterdam, Düsseldorf, or Luxembourg. Please ask your Patient Support agent for more information.
Four steps to access the medicines you need
How and where to access and buy Repatha: You can access Repatha from Everyone.org if it has not been approved or is not available in your country. Here’s how it works:
-
Step 1
Request your medicine
Search for the medicine you need on our website. Once on the medicine page, click on “Request medicine”, answer a couple of questions, and upload your prescription to speed things up. We’ll get back to you within 24 hours.
Can’t find the medicine you need? Contact us. If anyone can find it for you, it’s us.
-
Step 2
Get paperwork and cost details
Our expert team will give you all the necessary information, including:
the required paperwork for your country and situation.
a detailed price estimate, including medicine costs and any shipping, administrative, or import fees that may apply. -
Step 3
Confirm and pay for your order
Once you accept the price estimate, we’ll send you an order confirmation with payment instructions. As soon as you’ve made the payment, we’ll start working on getting you the medicine you need.
-
Step 4
Receive your medicine
Our experienced sourcing and logistics team will find your medicine and arrange for its safe shipping via one of our trusted specialized carriers. We’ll keep you updated every step of the way.
Repatha – Regulatory Approvals
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Andorra
Approved
Repatha is approved in Andorra through the European Medicines Agency centralized authorization, as Andorra often aligns with EU pharmaceutical regulations. The medicine is authorized for use in patients with hypercholesterolemia and cardiovascular risk management. Local health authorities ensure compliance with EMA guidelines for distribution and monitoring.
Regulatory body: EMA
Last updated: May 22, 2025
United Arab Emirates
Approved
The Ministry of Health and Prevention (MOHAP) in the United Arab Emirates has approved Repatha for the treatment of high cholesterol and prevention of cardiovascular events. The approval follows evaluation of clinical data supporting its efficacy and safety. It is available through licensed healthcare providers and pharmacies across the UAE.
Regulatory body: MOHAP
Last updated: May 22, 2025
Afghanistan
Not Approved
Repatha has not been approved by the Afghanistan National Medicines and Health Products Regulatory Authority. Due to limited regulatory infrastructure and market presence, the medicine is not authorized for use in Afghanistan. Patients requiring treatment with Repatha would need to seek alternatives or importation under special permissions.
Last updated: May 22, 2025
Antigua & Barbuda
Not Approved
Repatha has not been approved by the Antigua and Barbuda Pharmacy Board for use within the country. Limited regulatory infrastructure and market demand have contributed to the absence of formal approval. Patients may need to access the medicine through special importation channels if required.
Last updated: May 22, 2025
Anguilla
Not Approved
There is no clear public information on the regulatory approval status of Repatha in Anguilla. As a British Overseas Territory, medicines are often regulated under UK MHRA or local health authorities, but specific approval details for Repatha are not documented. Verification with local regulatory bodies is recommended.
Regulatory body: MHRA
Last updated: May 22, 2025
Albania
Approved
Repatha has received approval from the Albanian Medicines Agency (AMA) for use in patients with high cholesterol and cardiovascular disease risk. The approval follows alignment with European regulatory standards and allows for controlled distribution within Albania. The AMA monitors post-marketing safety and efficacy as part of ongoing regulatory oversight.
Regulatory body: Albanian Medicines Agency
Last updated: May 22, 2025
Armenia
Not Approved
There is limited publicly available information regarding the regulatory status of Repatha in Armenia. The national regulatory authority has not issued widely accessible approval statements, and it is unclear whether Repatha is authorized for use or distribution in the Armenian market.
Regulatory body: Armenia National Regulatory Authority
Last updated: May 22, 2025
Angola
Not Approved
Repatha has not received approval from the Angolan National Directorate of Pharmacy and Drugs for marketing in Angola. Regulatory processes and market access for innovative biologics like Repatha remain limited in Angola. Patients requiring this therapy may face challenges obtaining it locally.
Regulatory body: Angola National Regulatory Authority
Last updated: May 22, 2025
Antarctica
Not Approved
Antarctica does not have a regulatory authority for medicines, and Repatha is not approved or regulated for use on the continent. Medical supplies in Antarctica are managed by individual national programs and research stations, with no formal pharmaceutical approvals in place.
Last updated: May 22, 2025
Argentina
Approved
Repatha (evolocumab) is approved in Argentina by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). The approval covers its use for lowering LDL cholesterol in patients with hypercholesterolemia and those at high cardiovascular risk. ANMAT has authorized its prescription under specific clinical guidelines consistent with international standards.
Regulatory body: ANMAT
Last updated: May 22, 2025
American Samoa
Not Approved
There is no publicly available information regarding the approval status of Repatha in American Samoa. As a US territory, medicines are typically regulated under the US FDA framework, but specific local approvals or availability data for Repatha are not documented. Further inquiry with local health authorities would be necessary.
Regulatory body: FDA
Last updated: May 22, 2025
Austria
Approved
Repatha has received approval from the Austrian Federal Office for Safety in Health Care (BASG) and is authorized for use within Austria. It is indicated for patients with primary hypercholesterolemia or mixed dyslipidemia who require additional LDL cholesterol lowering. The approval is consistent with the European Medicines Agency's authorization.
Regulatory body: BASG
Last updated: May 22, 2025
Australia
Approved
Repatha is approved by the Therapeutic Goods Administration (TGA) in Australia for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. The TGA approval includes use as an adjunct to diet and maximally tolerated statin therapy. This approval is aligned with international guidelines for cardiovascular risk reduction.
Regulatory body: TGA
Last updated: May 22, 2025
Aruba
Not Approved
No specific information is available on the approval status of Repatha in Aruba. As a constituent country within the Kingdom of the Netherlands, Aruba may follow regulatory decisions from the European Medicines Agency or local authorities, but no explicit approval details have been confirmed.
Regulatory body: Aruba National Regulatory Authority
Last updated: May 22, 2025
Åland Islands
Approved
Repatha is approved in the Åland Islands through the European Medicines Agency (EMA) centralized procedure, as Åland is part of Finland and the EU regulatory framework. The EMA has authorized Repatha for the treatment of hypercholesterolemia and cardiovascular risk reduction. This approval ensures availability under the Finnish Medicines Agency (Fimea) jurisdiction.
Regulatory body: EMA
Last updated: May 22, 2025
Azerbaijan
Not Approved
There is no publicly available detailed information regarding the approval of Repatha in Azerbaijan. The State Agency on Mandatory Health Insurance or other relevant authorities have not released clear statements about its regulatory status in the country.
Regulatory body: Azerbaijan National Regulatory Authority
Last updated: May 22, 2025
Bosnia & Herzegovina
Approved
Repatha is approved by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina. It is authorized for patients with familial hypercholesterolemia and those requiring additional LDL cholesterol reduction. The approval is based on clinical trial data and aligns with European regulatory standards.
Regulatory body: Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
Last updated: May 22, 2025
Barbados
Not Approved
There is no clear publicly available information regarding the regulatory approval of Repatha in Barbados. The Barbados Pharmacy Council or Ministry of Health has not issued specific statements about its approval or market availability.
Regulatory body: Barbados National Regulatory Authority
Last updated: May 22, 2025
Bangladesh
Approved
Repatha has been approved by the Directorate General of Drug Administration (DGDA) in Bangladesh for the treatment of hypercholesterolemia. The approval allows for its use as an adjunct to diet and other lipid-lowering therapies in patients at high cardiovascular risk. The DGDA continues to monitor its post-marketing safety profile.
Regulatory body: DGDA
Last updated: May 22, 2025
Belgium
Approved
Repatha is approved by the Federal Agency for Medicines and Health Products (FAMHP) in Belgium. It is authorized for use in patients with familial hypercholesterolemia and those at high risk for cardiovascular disease who require additional LDL cholesterol lowering. The approval is consistent with the European Medicines Agency's (EMA) authorization.
Regulatory body: Federal Agency for Medicines and Health Products (FAMHP)
Last updated: May 22, 2025
Burkina Faso
Not Approved
There is no publicly available information regarding the approval status of Repatha in Burkina Faso. Regulatory oversight in Burkina Faso is managed by the National Directorate of Pharmacy and Medicine, but no specific data on Repatha approval is accessible.
Regulatory body: Burkina Faso National Regulatory Authority
Last updated: May 22, 2025
Bulgaria
Approved
Repatha is approved in Bulgaria through the European Medicines Agency (EMA) centralized procedure. The Bulgarian Drug Agency recognizes EMA approvals, allowing Repatha to be prescribed for patients with high cholesterol and cardiovascular risk. The approval includes specific indications aligned with EMA guidelines.
Regulatory body: EMA
Last updated: May 22, 2025
Bahrain
Approved
Repatha is approved in Bahrain by the National Health Regulatory Authority (NHRA). The approval includes its use for patients with hypercholesterolemia and those at high risk of cardiovascular events, consistent with international clinical guidelines. The NHRA monitors its use to ensure safety and efficacy in the Bahraini population.
Regulatory body: NHRA
Last updated: May 22, 2025
Burundi
Not Approved
Repatha's regulatory approval status in Burundi is not documented in publicly accessible sources. The Burundi Ministry of Public Health oversees medicine approvals, but no specific information on Repatha is available.
Regulatory body: Burundi National Regulatory Authority
Last updated: May 22, 2025
Benin
Not Approved
Repatha is not currently approved by the Agence Nationale de la Sécurité Sanitaire des Produits Pharmaceutiques (ANSSPP) in Benin. The medicine has not been registered for local use, and access may be limited to special import permits or international aid programs.
Last updated: May 22, 2025
St. Barthélemy
Approved
Saint Barthélemy, as a French overseas collectivity, follows the regulatory approvals granted by the European Medicines Agency (EMA) and the French National Agency for Medicines and Health Products Safety (ANSM). Repatha is approved for use in this territory under the same conditions as in mainland France, primarily for patients with hypercholesterolemia requiring LDL cholesterol reduction.
Regulatory body: ANSM
Last updated: May 22, 2025
Bermuda
Approved
Repatha has been approved by the Bermuda Health Regulatory Authority for use in managing high cholesterol and reducing cardiovascular risk. The approval aligns with standards set by major regulatory agencies such as the FDA and EMA. It is available through prescription with appropriate clinical oversight.
Regulatory body: Bermuda Health Regulatory Authority
Last updated: May 22, 2025
Brunei
Not Approved
There is no clear public record of Repatha's approval by Brunei's Ministry of Health. Brunei typically follows approvals from major regulatory agencies, but specific authorization for Repatha has not been confirmed.
Regulatory body: Brunei National Regulatory Authority
Last updated: May 22, 2025
Bolivia
Not Approved
The regulatory status of Repatha in Bolivia is unclear due to limited publicly available information from the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED). It is uncertain whether the medicine has been formally approved or registered for use in the country.
Regulatory body: Bolivia National Regulatory Authority
Last updated: May 22, 2025
Brazil
Approved
Repatha (evolocumab) is approved by the Brazilian Health Regulatory Agency (ANVISA) for use in patients with hypercholesterolemia and those at high cardiovascular risk. The approval is based on clinical evidence demonstrating its efficacy in lowering LDL cholesterol levels. ANVISA has authorized its marketing under specified conditions including prescription use.
Regulatory body: ANVISA
Last updated: May 22, 2025
Bahamas
Not Approved
The regulatory approval status of Repatha in the Bahamas is not clearly documented in publicly accessible sources. The Bahamas Pharmacy Council or Ministry of Health has not published definitive information regarding its authorization or availability.
Regulatory body: Bahamas National Regulatory Authority
Last updated: May 22, 2025
Bhutan
Not Approved
Repatha has not been approved by the Ministry of Health of Bhutan. There is no evidence of registration or marketing authorization for this medicine in Bhutan, and it is likely unavailable through conventional healthcare channels.
Last updated: May 22, 2025
Bouvet Island
Not Approved
Bouvet Island is an uninhabited territory with no regulatory authority or pharmaceutical market. Therefore, Repatha is not approved or available on Bouvet Island.
Last updated: May 22, 2025
Botswana
Not Approved
Repatha has not been approved by the Botswana Medicines Regulatory Authority (BoMRA). There is no record of marketing authorization, and the medicine is not widely available in the country. Access may be limited to special importation under controlled conditions.
Last updated: May 22, 2025
Belarus
Approved
Repatha has been approved by the Ministry of Health of the Republic of Belarus for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval follows evaluation of clinical data supporting its efficacy and safety profile. It is available under prescription with specific indications aligned with international guidelines.
Regulatory body: Ministry of Health of the Republic of Belarus
Last updated: May 22, 2025
Belize
Not Approved
Repatha has not received regulatory approval from the Belize Ministry of Health. There is no public record of its registration or authorization for use within Belize. Patients requiring this medication may need to explore importation under special access or compassionate use programs.
Regulatory body: Belize National Regulatory Authority
Last updated: May 22, 2025
Canada
Approved
Repatha is approved by Health Canada for the treatment of patients with hypercholesterolemia and those at high risk of cardiovascular events. The approval was granted following comprehensive review of clinical trial data demonstrating safety and efficacy. Health Canada has authorized its use under prescription with specific labeling requirements.
Regulatory body: Health Canada
Last updated: May 22, 2025
Cocos (Keeling) Islands
Not Approved
Similar to Christmas Island, the Cocos (Keeling) Islands fall under Australian jurisdiction and rely on the Therapeutic Goods Administration (TGA) for pharmaceutical approvals. There is no distinct regulatory approval record for Repatha specific to this territory. Availability is subject to Australian regulatory decisions.
Regulatory body: TGA
Last updated: May 22, 2025
Congo - Kinshasa
Not Approved
The regulatory status of Repatha in Congo - Kinshasa is not well documented. The Congolese National Medicines Regulatory Authority (ANAM) has not publicly confirmed approval or rejection of this medicine. As such, the approval status cannot be definitively stated.
Regulatory body: Congo - Kinshasa National Regulatory Authority
Last updated: May 22, 2025
Central African Republic
Not Approved
Regulatory information for Repatha in the Central African Republic is not readily available. The national medicines regulatory authority has limited public documentation on the approval status of newer biologic therapies. It is recommended to contact local health authorities for definitive information.
Regulatory body: Central African Republic National Regulatory Authority
Last updated: May 22, 2025
Congo - Brazzaville
Not Approved
There is limited publicly available information regarding the regulatory approval status of Repatha in Congo - Brazzaville. The national regulatory authority, the National Agency for Pharmaceutical Regulation and Control (ANRP), has not published clear data on this product. Therefore, the approval status remains uncertain.
Regulatory body: Congo - Brazzaville National Regulatory Authority
Last updated: May 22, 2025
Switzerland
Approved
Repatha (evolocumab) is approved by Swissmedic, the Swiss Agency for Therapeutic Products, for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval is based on robust clinical data demonstrating its efficacy in lowering LDL cholesterol levels. Swissmedic monitors its use under standard regulatory conditions.
Regulatory body: Swissmedic
Last updated: May 22, 2025
Côte d’Ivoire
Not Approved
There is no publicly accessible information confirming the approval status of Repatha in Côte d’Ivoire. The regulatory authority, the National Agency for Pharmaceutical Regulation (ANRP), has not issued clear statements regarding this product. Thus, the approval status is currently unknown.
Regulatory body: Côte d’Ivoire National Regulatory Authority
Last updated: May 22, 2025
Cook Islands
Not Approved
The Cook Islands Medicines Regulatory Authority has limited publicly available information regarding the approval of Repatha. Given the small market size and reliance on approvals from larger regulatory bodies, the status remains unclear and is considered unknown.
Regulatory body: Cook Islands National Regulatory Authority
Last updated: May 22, 2025
Chile
Approved
Repatha has been approved by the Instituto de Salud Pública de Chile (ISP) for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval follows submission of clinical data demonstrating efficacy and safety consistent with international standards. It is available under prescription and subject to national pharmacovigilance requirements.
Regulatory body: Instituto de Salud Pública de Chile (ISP)
Last updated: May 22, 2025
Cameroon
Not Approved
Repatha's approval status in Cameroon is not publicly documented. The National Drug Quality Control Laboratory and Ministry of Public Health regulate medicines, but no specific data on Repatha approval is available at this time.
Regulatory body: Cameroon National Regulatory Authority
Last updated: May 22, 2025
China
Approved
Repatha is approved by the National Medical Products Administration (NMPA) of China for use in patients with hyperlipidemia and cardiovascular risk reduction. The approval was granted after comprehensive review of clinical trial data, including local population studies. The drug is available through prescription and is included in certain provincial reimbursement lists.
Regulatory body: National Medical Products Administration (NMPA)
Last updated: May 22, 2025
Colombia
Approved
Repatha is approved by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia for treatment of hypercholesterolemia and prevention of cardiovascular events. The approval was based on clinical trial data and aligns with international regulatory standards. The medication is available through prescription and monitored under national pharmacovigilance programs.
Regulatory body: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
Last updated: May 22, 2025
Costa Rica
Approved
Repatha has been approved by the Costa Rican Ministry of Health (Ministerio de Salud) for the treatment of hypercholesterolemia and cardiovascular risk reduction. The approval followed evaluation of clinical data supporting its efficacy and safety. It is available under prescription with specific indications aligned with international guidelines.
Regulatory body: Ministerio de Salud
Last updated: May 22, 2025
Cuba
Not Approved
Repatha is not approved by the Cuban regulatory authority, the Center for State Control of Medicines, Equipment and Medical Devices (CECMED). There is no record of marketing authorization or clinical use approval within Cuba, likely due to limited access and local pharmaceutical policies.
Last updated: May 22, 2025
Cape Verde
Not Approved
There is limited publicly available information regarding the regulatory approval status of Repatha in Cape Verde. The national regulatory authority does not have widely accessible records on this medicine, making it unclear whether it has been approved for use. Healthcare providers should consult local health authorities for the most current status.
Regulatory body: Cape Verde National Regulatory Authority
Last updated: May 22, 2025
Christmas Island
Not Approved
Christmas Island, being an external territory of Australia, generally follows the Australian Therapeutic Goods Administration (TGA) approvals. However, specific local regulatory approval records for Repatha are not separately maintained. Access to the medicine is likely governed under Australian regulations.
Regulatory body: TGA
Last updated: May 22, 2025
Cyprus
Approved
Repatha has received approval in Cyprus through the national competent authority, following the centralized authorization by the European Medicines Agency (EMA). It is indicated for patients with hypercholesterolemia and is prescribed under specific clinical criteria to manage cardiovascular risk.
Regulatory body: Cyprus Pharmaceutical Services
Last updated: May 22, 2025
Czechia
Approved
The State Institute for Drug Control (SÚKL) in Czechia has approved Repatha in line with the European Medicines Agency's centralized marketing authorization. It is indicated for adults with primary hypercholesterolemia or mixed dyslipidemia and is available by prescription with clinical monitoring.
Regulatory body: SÚKL
Last updated: May 22, 2025
Germany
Approved
Repatha is approved in Germany by the Federal Institute for Drugs and Medical Devices (BfArM). The approval aligns with the European Medicines Agency (EMA) authorization, allowing its use for lowering LDL cholesterol in patients with hypercholesterolemia and those at high cardiovascular risk. The medicine is available under prescription with specific clinical guidelines.
Regulatory body: BfArM
Last updated: May 22, 2025
Djibouti
Not Approved
There is limited publicly available information regarding the approval status of Repatha in Djibouti. The country’s regulatory framework is still developing, and specific approvals for biologics like Repatha have not been clearly documented. It is recommended to consult local health authorities for the most current status.
Regulatory body: Djibouti National Regulatory Authority
Last updated: May 22, 2025
Denmark
Approved
Repatha is approved in Denmark by the Danish Medicines Agency (Lægemiddelstyrelsen) following EMA's centralized approval. It is indicated for the treatment of high cholesterol and prevention of cardiovascular events, prescribed under specific guidelines to ensure patient safety and efficacy.
Regulatory body: Danish Medicines Agency
Last updated: May 22, 2025
Dominica
Not Approved
Repatha's regulatory approval status in Dominica is not well documented in international pharmaceutical databases. Dominica relies on regional regulatory harmonization efforts, but no explicit approval information is publicly available. Verification with the Dominica Ministry of Health is advised for precise details.
Regulatory body: Dominica National Regulatory Authority
Last updated: May 22, 2025
Dominican Republic
Approved
Repatha has been approved by the Dominican Republic’s Ministry of Public Health and Social Assistance (Ministerio de Salud Pública y Asistencia Social). The approval is based on clinical data supporting its use for lowering LDL cholesterol in patients with hyperlipidemia and cardiovascular risk. The regulatory authority monitors post-marketing safety as per local requirements.
Regulatory body: Ministerio de Salud Pública y Asistencia Social
Last updated: May 22, 2025
Algeria
Approved
Repatha is approved by the Algerian National Agency for Pharmaceutical Products (ANPP) for the treatment of hyperlipidemia in patients at high cardiovascular risk. The regulatory approval was granted following submission of clinical data consistent with international standards. The ANPP continues to oversee the medicine's safety profile in the Algerian market.
Regulatory body: ANPP
Last updated: May 22, 2025
Ecuador
Approved
Repatha is approved by Ecuador’s Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA). The approval covers its use in adults with established cardiovascular disease requiring additional LDL cholesterol reduction. ARCSA has evaluated the clinical trial data and granted marketing authorization with standard pharmacovigilance obligations.
Regulatory body: ARCSA
Last updated: May 22, 2025
Estonia
Approved
Repatha is approved in Estonia through the European Medicines Agency (EMA) centralized procedure. The Estonian State Agency of Medicines recognizes this approval, allowing Repatha to be marketed for patients with hypercholesterolemia and cardiovascular disease. The approval includes ongoing pharmacovigilance as per EMA guidelines.
Regulatory body: European Medicines Agency
Last updated: May 22, 2025
Egypt
Approved
Repatha has received approval from the Egyptian Drug Authority (EDA) for the treatment of patients with hypercholesterolemia and cardiovascular risk factors. The EDA reviewed comprehensive clinical trial data and approved the biologic under standard regulatory pathways. Ongoing monitoring and reporting of adverse events are mandated.
Regulatory body: Egyptian Drug Authority
Last updated: May 22, 2025
Western Sahara
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in Western Sahara. Given the limited regulatory infrastructure and the political status of the territory, it is unclear whether any formal approval process has been conducted. Healthcare access and pharmaceutical regulation in this region remain largely undocumented.
Regulatory body: Western Sahara National Regulatory Authority
Last updated: May 22, 2025
Eritrea
Not Approved
No publicly available information confirms the approval of Repatha in Eritrea. The country’s regulatory environment for advanced biologics is not well documented internationally. For accurate status, inquiries should be directed to the Eritrean Ministry of Health or equivalent regulatory body.
Regulatory body: Eritrea National Regulatory Authority
Last updated: May 22, 2025
Spain
Approved
Repatha is authorized in Spain through the European Medicines Agency (EMA) centralized procedure and is regulated locally by the Spanish Agency of Medicines and Medical Devices (AEMPS). It is approved for lowering LDL cholesterol in patients with familial hypercholesterolemia and cardiovascular disease. Its use is subject to national reimbursement and clinical guidelines.
Regulatory body: AEMPS
Last updated: May 22, 2025
Ethiopia
Not Approved
Repatha has not been approved by the Ethiopian Food and Drug Authority (EFDA) for use within Ethiopia. There is no public record of regulatory submission or approval for this medicine in the Ethiopian market. Patients requiring Repatha would need to consider alternative lipid-lowering therapies approved locally.
Last updated: May 22, 2025
Finland
Approved
Repatha is approved in Finland by the Finnish Medicines Agency (Fimea) and is available for patients requiring treatment to lower LDL cholesterol. The approval aligns with the European Medicines Agency (EMA) authorization, as Finland is an EU member state. Prescribing is subject to national guidelines and reimbursement policies.
Regulatory body: Finnish Medicines Agency (Fimea)
Last updated: May 22, 2025
Fiji
Not Approved
Repatha has not received approval from the Fiji Medicines and Medical Devices Authority (FMDA) for marketing or use in Fiji. There is no publicly available information indicating regulatory submission or authorization. Patients in Fiji requiring this treatment may need to explore alternative options or importation under special access schemes.
Regulatory body: Fiji National Regulatory Authority
Last updated: May 22, 2025
Falkland Islands
Not Approved
There is no specific regulatory body in the Falkland Islands responsible for medicine approvals, and no direct approval status for Repatha is available. Medicines are generally supplied under the regulatory frameworks of the United Kingdom. Therefore, the approval status of Repatha in the Falkland Islands is considered unknown.
Regulatory body: Falkland Islands National Regulatory Authority
Last updated: May 22, 2025
Micronesia
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in Micronesia. The country has limited pharmaceutical regulatory infrastructure, and specific approvals for biologics like Repatha are not well documented. Therefore, the approval status remains unknown.
Regulatory body: Micronesia National Regulatory Authority
Last updated: May 22, 2025
Faroe Islands
Approved
Repatha is approved for use in the Faroe Islands under the regulation of the Danish Medicines Agency, which oversees pharmaceutical approvals for the territory. The approval includes indications for lowering LDL cholesterol in patients with hypercholesterolemia and cardiovascular risk. Access to Repatha is consistent with EU regulatory standards due to the Faroe Islands' association with Denmark.
Regulatory body: Danish Medicines Agency
Last updated: May 22, 2025
France
Approved
Repatha is approved by the French National Agency for the Safety of Medicines and Health Products (ANSM) and is available for use in France. The approval follows the European Medicines Agency (EMA) centralized authorization, allowing its use in patients with hypercholesterolemia and cardiovascular disease risk. The medicine is reimbursed under specific clinical criteria.
Regulatory body: ANSM
Last updated: May 22, 2025
Gabon
Not Approved
Repatha has not been approved by the Agence Nationale de la Sécurité du Médicament et des Produits de Santé (ANSMPS) in Gabon. There is no public record of regulatory authorization or marketing approval for this medicine in Gabonese territory. Patients requiring this treatment would likely need to seek alternatives or importation under special regulatory provisions.
Last updated: May 22, 2025
United Kingdom
Approved
Repatha is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of hypercholesterolemia and to reduce cardiovascular risk. Additionally, the National Institute for Health and Care Excellence (NICE) provides guidance on its use within the NHS, including specific patient eligibility criteria. This ensures regulated and evidence-based access to the medicine.
Regulatory body: MHRA
Last updated: May 22, 2025
Grenada
Not Approved
There is no clear public information regarding the approval status of Repatha in Grenada. The Grenada Pharmacy Board or relevant regulatory authority has not published data confirming approval or rejection. Thus, the status remains unknown.
Regulatory body: Grenada National Regulatory Authority
Last updated: May 22, 2025
Georgia
Not Approved
Repatha's approval status in Georgia is not well-documented in publicly accessible regulatory databases. The Georgian National Agency for Medicines has not provided clear information on the approval or rejection of this product. Consequently, the status is considered unknown.
Regulatory body: Georgia National Regulatory Authority
Last updated: May 22, 2025
French Guiana
Approved
As an overseas department of France, French Guiana follows the regulatory approvals granted by the French National Agency for the Safety of Medicines and Health Products (ANSM). Therefore, Repatha is approved and accessible in French Guiana under the same conditions as mainland France. The medicine is subject to French healthcare regulations and reimbursement policies.
Regulatory body: ANSM
Last updated: May 22, 2025
Guernsey
Approved
Repatha is approved in Guernsey through the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, which extends to the Crown dependencies. It is authorized for use in patients with familial hypercholesterolemia and established cardiovascular disease. Prescribing follows UK clinical guidelines.
Regulatory body: MHRA
Last updated: May 22, 2025
Ghana
Not Approved
There is limited publicly available information regarding the approval of Repatha by the Ghana Food and Drugs Authority (FDA). No official records confirm its registration or market authorization, leaving the approval status uncertain at this time.
Regulatory body: FDA
Last updated: May 22, 2025
Gibraltar
Approved
Repatha is approved in Gibraltar, following authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom. Gibraltar, as a British Overseas Territory, generally aligns with UK regulatory decisions. The medicine is accessible under prescription for indicated cardiovascular conditions.
Regulatory body: MHRA
Last updated: May 22, 2025
Greenland
Approved
Repatha is considered approved in Greenland through regulatory alignment with Denmark and the European Medicines Agency. The Danish Medicines Agency oversees pharmaceutical approvals for Greenland, and Repatha is authorized for use in indicated patient populations. Access is typically managed via prescription and healthcare provider oversight.
Regulatory body: Danish Medicines Agency
Last updated: May 22, 2025
Gambia
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in Gambia. The National Medicines Regulatory Authority in Gambia has not issued any official statements or approvals concerning this medicine. Therefore, its approval status remains unclear.
Regulatory body: Gambia National Regulatory Authority
Last updated: May 22, 2025
Guinea
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in Guinea. The national regulatory authority has not issued clear guidance or approval statements for this medicine. Therefore, its availability and approval status remain uncertain.
Regulatory body: Guinea National Regulatory Authority
Last updated: May 22, 2025
Guadeloupe
Approved
As an overseas region of France, Guadeloupe follows the regulatory decisions of the European Medicines Agency and the French National Agency for the Safety of Medicines and Health Products (ANSM). Repatha is approved and available in Guadeloupe under these regulatory frameworks for indicated cardiovascular conditions.
Regulatory body: ANSM
Last updated: May 22, 2025
Equatorial Guinea
Not Approved
Repatha’s approval status in Equatorial Guinea is not documented in accessible regulatory records. Given the limited pharmaceutical regulatory infrastructure, it is unclear if Repatha is authorized for use. Local health authorities should be contacted for specific regulatory guidance.
Regulatory body: Equatorial Guinea National Regulatory Authority
Last updated: May 22, 2025
Greece
Approved
Repatha has been approved in Greece by the National Organization for Medicines (EOF), consistent with the European Medicines Agency's centralized approval. It is indicated for patients with hypercholesterolemia and those requiring additional LDL cholesterol reduction. The medicine is available through prescription with reimbursement conditions applied.
Regulatory body: EOF
Last updated: May 22, 2025
South Georgia & South Sandwich Islands
Not Approved
Repatha is not approved in South Georgia & South Sandwich Islands due to the territory's lack of a dedicated pharmaceutical regulatory authority and very limited healthcare infrastructure. Medicines are typically supplied through the United Kingdom or other jurisdictions, and no formal approval exists locally.
Last updated: May 22, 2025
Guatemala
Approved
Repatha is approved in Guatemala by the Ministry of Public Health and Social Assistance (MSPAS). The approval is based on clinical data supporting its efficacy in lowering LDL cholesterol in patients with hyperlipidemia and cardiovascular risk. It is available under prescription with specific guidelines for use in high-risk patients.
Regulatory body: MSPAS
Last updated: May 22, 2025
Guam
Approved
Repatha is approved in Guam under the jurisdiction of the United States Food and Drug Administration (FDA). The approval covers its use for lowering LDL cholesterol in patients with hypercholesterolemia and cardiovascular risk. The medicine is available by prescription in Guam consistent with US regulatory standards.
Regulatory body: FDA
Last updated: May 22, 2025
Guinea-Bissau
Not Approved
Repatha's approval status in Guinea-Bissau is not documented in accessible regulatory databases. The national health authority has not published any formal approval or rejection notices. Consequently, the regulatory status of this medicine in Guinea-Bissau is considered unknown.
Regulatory body: Guinea-Bissau National Regulatory Authority
Last updated: May 22, 2025
Guyana
Not Approved
Repatha is not currently approved by the Guyana Pharmacy Council or the Ministry of Health for use in the Guyanese market. Despite its global approvals, the medicine has not yet undergone the full regulatory review process in Guyana. Patients requiring this treatment may need to access it through special importation channels.
Regulatory body: Guyana National Regulatory Authority
Last updated: May 22, 2025
Hong Kong SAR China
Approved
Repatha is approved in Hong Kong by the Department of Health's Pharmacy and Poisons Board. The approval covers its use in adults with primary hyperlipidemia or mixed dyslipidemia who require additional LDL cholesterol lowering. The medication is available through prescription and is included in clinical treatment guidelines.
Regulatory body: Pharmacy and Poisons Board
Last updated: May 22, 2025
Heard & McDonald Islands
Not Approved
Heard & McDonald Islands do not have a local regulatory authority for pharmaceutical approvals due to their status as uninhabited territories. Consequently, Repatha is not approved or registered for use in this region. Any use would be governed by the regulations of the administering country, Australia.
Last updated: May 22, 2025
Honduras
Approved
Repatha is approved in Honduras by the Agencia de Regulación Sanitaria (ARSA). The approval includes indications for patients with hypercholesterolemia and those at high risk of cardiovascular events. The medicine is available by prescription and subject to national pharmacovigilance monitoring.
Regulatory body: ARSA
Last updated: May 22, 2025
Croatia
Approved
Repatha is approved in Croatia by the Agency for Medicinal Products and Medical Devices (HALMED). The approval is consistent with the European Medicines Agency (EMA) authorization, allowing its use for lowering LDL cholesterol in patients with specific cardiovascular risk profiles. It is available through prescription under defined clinical guidelines.
Regulatory body: HALMED
Last updated: May 22, 2025
Haiti
Not Approved
Repatha has not received regulatory approval from the Haitian Ministry of Public Health and Population. The medicine is not registered for commercial distribution in Haiti, and no formal authorization has been granted. Access to Repatha in Haiti is therefore limited and may require special import permits.
Last updated: May 22, 2025
Hungary
Approved
Repatha is approved in Hungary by the National Institute of Pharmacy and Nutrition (OGYÉI). It is authorized for use in patients with familial hypercholesterolemia and those with established cardiovascular disease requiring LDL cholesterol reduction. The approval is aligned with European Medicines Agency (EMA) recommendations and includes reimbursement conditions.
Regulatory body: OGYÉI
Last updated: May 22, 2025
Indonesia
Approved
Repatha is approved by Indonesia's National Agency of Drug and Food Control (BPOM) for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval is based on international clinical data and local regulatory review, allowing its use as an adjunct to diet and other lipid-lowering therapies.
Regulatory body: BPOM
Last updated: May 22, 2025
Ireland
Approved
Repatha is approved in Ireland through the European Medicines Agency (EMA) centralized authorization. The Health Products Regulatory Authority (HPRA) in Ireland recognizes this approval, permitting Repatha's use for lowering LDL cholesterol in adults with primary hypercholesterolemia or mixed dyslipidemia. It is indicated as an adjunct to diet and maximally tolerated statin therapy.
Regulatory body: EMA
Last updated: May 22, 2025
Israel
Approved
Repatha has been approved by the Israeli Ministry of Health for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval was granted after review of clinical trial data demonstrating efficacy and safety, allowing its use in patients who require additional LDL cholesterol lowering beyond standard therapy.
Regulatory body: Israeli Ministry of Health
Last updated: May 22, 2025
Isle of Man
Approved
Repatha is available in the Isle of Man as the territory follows the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) approvals. Given MHRA's authorization of Repatha, it is considered approved and accessible for patients requiring LDL cholesterol reduction under clinical guidance.
Regulatory body: MHRA
Last updated: May 22, 2025
India
Approved
Repatha has received regulatory approval from the Central Drugs Standard Control Organization (CDSCO) in India. It is authorized for use in patients with familial hypercholesterolemia and those requiring additional LDL cholesterol lowering despite statin therapy. The approval follows evaluation of clinical trial data supporting its efficacy and safety in the Indian population.
Regulatory body: CDSCO
Last updated: May 22, 2025
British Indian Ocean Territory
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in the British Indian Ocean Territory. Given the territory's limited local regulatory infrastructure, medicines are typically governed by approvals in the United Kingdom or other jurisdictions.
Regulatory body: British Indian Ocean Territory National Regulatory Authority
Last updated: May 22, 2025
Iraq
Not Approved
The regulatory approval status of Repatha in Iraq is not well documented in accessible sources. It is unclear if the Iraqi Ministry of Health has authorized Repatha for use, and no official public records confirm its approval or availability in the Iraqi pharmaceutical market.
Regulatory body: Iraq National Regulatory Authority
Last updated: May 22, 2025
Iran
Not Approved
There is limited publicly available information regarding the regulatory status of Repatha in Iran. The approval status with the Iranian Food and Drug Administration (IFDA) is not clearly documented, and it is uncertain whether Repatha is authorized for marketing or clinical use in this country.
Regulatory body: FDA
Last updated: May 22, 2025
Iceland
Approved
Repatha is approved in Iceland through the European Medicines Agency (EMA) centralized procedure. The Icelandic Medicines Agency recognizes EMA approvals, allowing Repatha to be marketed for lowering LDL cholesterol in patients with hypercholesterolemia and cardiovascular risk. The approval includes use as an adjunct to diet and maximally tolerated statin therapy.
Regulatory body: EMA
Last updated: May 22, 2025
Italy
Approved
Repatha is approved in Italy through the European Medicines Agency (EMA) centralized procedure. The Italian Medicines Agency (AIFA) recognizes this approval, enabling Repatha's use for patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet and statin therapy. Specific reimbursement criteria may apply within the Italian healthcare system.
Regulatory body: EMA
Last updated: May 22, 2025
Jersey
Approved
Repatha is approved for use in Jersey, regulated under the Medicines and Healthcare products Regulatory Agency (MHRA) framework as Jersey follows UK regulatory standards. The approval covers treatment for patients with high cholesterol and cardiovascular risk. Access is typically through prescription and aligned with UK clinical guidelines.
Regulatory body: MHRA
Last updated: May 22, 2025
Jamaica
Not Approved
Repatha has not received regulatory approval from the Ministry of Health and Wellness in Jamaica. There is no official record of authorization for marketing or clinical use, and the medication is not currently available through standard pharmaceutical channels in the country.
Last updated: May 22, 2025
Jordan
Approved
Repatha has received approval from the Jordan Food and Drug Administration (JFDA) for the management of hyperlipidemia and cardiovascular risk reduction. The approval is based on international clinical data and local regulatory review. It is prescribed under specialist supervision with adherence to approved indications.
Regulatory body: JFDA
Last updated: May 22, 2025
Japan
Approved
Repatha (evolocumab) is approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval followed comprehensive clinical trials demonstrating its efficacy and safety in the Japanese population. It is available under prescription with specific indications related to LDL cholesterol management.
Regulatory body: PMDA
Last updated: May 22, 2025
Kenya
Approved
Repatha is approved by the Pharmacy and Poisons Board (PPB) of Kenya for use in patients with hypercholesterolemia and at risk of cardiovascular events. The approval reflects the PPB's assessment of safety and efficacy data. Access is prescription-based and subject to local clinical guidelines.
Regulatory body: Pharmacy and Poisons Board (PPB)
Last updated: May 22, 2025
Kyrgyzstan
Approved
Repatha has been approved by the Ministry of Health of Kyrgyzstan for use in patients with elevated LDL cholesterol and cardiovascular risk. The approval followed review of clinical efficacy and safety data consistent with international standards. It is available through prescription and monitored use.
Regulatory body: Ministry of Health of Kyrgyzstan
Last updated: May 22, 2025
Cambodia
Not Approved
There is no confirmed information regarding Repatha's approval by the Cambodian Ministry of Health. Cambodia's regulatory framework is evolving, and specific approvals for newer biologics like Repatha may not yet be established or publicly disclosed.
Regulatory body: Cambodia National Regulatory Authority
Last updated: May 22, 2025
Kiribati
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in Kiribati. Given the small market size and limited local regulatory infrastructure, it is unclear whether Repatha has been submitted for approval or is available through special access programs.
Regulatory body: Kiribati National Regulatory Authority
Last updated: May 22, 2025
Comoros
Not Approved
There is insufficient public information regarding the approval status of Repatha in Comoros. The national regulatory authority does not have widely accessible records for biologic medicines. Healthcare providers should consult local health officials for the most accurate and current information.
Regulatory body: Comoros National Regulatory Authority
Last updated: May 22, 2025
St. Kitts & Nevis
Not Approved
No specific data is available on the approval status of Repatha by the St. Kitts & Nevis regulatory authorities. The country often follows approvals from major regulatory agencies such as the FDA or EMA, but local registration status remains unclear. Patients and healthcare providers should consult local health authorities for up-to-date information.
Regulatory body: FDA
Last updated: May 22, 2025
North Korea
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in North Korea. Due to the country's isolated pharmaceutical regulatory environment and limited data transparency, it is unclear whether Repatha is approved or available for use.
Regulatory body: North Korea National Regulatory Authority
Last updated: May 22, 2025
South Korea
Approved
Repatha has been approved by the Ministry of Food and Drug Safety (MFDS) in South Korea. The approval covers its use in patients with hypercholesterolemia and cardiovascular risk requiring additional LDL cholesterol reduction. The MFDS reviewed comprehensive clinical trial data before granting marketing authorization.
Regulatory body: MFDS
Last updated: May 22, 2025
Kuwait
Approved
Repatha is approved in Kuwait by the Kuwait Ministry of Health for the treatment of hypercholesterolemia and prevention of cardiovascular disease. The approval is based on international clinical trial data and local regulatory review processes. It is dispensed under prescription with specific clinical indications.
Regulatory body: Kuwait Ministry of Health
Last updated: May 22, 2025
Cayman Islands
Not Approved
The Cayman Islands do not have a publicly accessible independent regulatory approval record for Repatha. Given the territory's reliance on approvals from larger regulatory bodies such as the FDA or EMA, it is likely that access depends on importation under specific regulations rather than local approval. Official confirmation should be sought from the Cayman Islands Health Regulatory Authority.
Regulatory body: FDA
Last updated: May 22, 2025
Kazakhstan
Approved
Repatha is approved in Kazakhstan by the Ministry of Healthcare for the treatment of patients with high cholesterol and cardiovascular disease risk. The approval was granted following evaluation of clinical evidence and aligns with regional regulatory standards. It is available through prescription with monitoring requirements.
Regulatory body: Ministry of Healthcare of Kazakhstan
Last updated: May 22, 2025
Laos
Not Approved
There is no clear information on the approval status of Repatha in Laos. The Lao Food and Drug Department has not publicly disclosed approval details, and availability may be limited or managed through special importation channels. Further regulatory updates are needed for confirmation.
Regulatory body: Laos National Regulatory Authority
Last updated: May 22, 2025
Lebanon
Approved
Repatha has been approved by the Lebanese Ministry of Public Health for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval follows submission of clinical data supporting its efficacy and safety. It is available under prescription with specific indications aligned with international guidelines.
Regulatory body: Lebanese Ministry of Public Health
Last updated: May 22, 2025
St. Lucia
Not Approved
Repatha's regulatory approval status in St. Lucia is not well documented in publicly accessible sources. The country’s medicines regulatory framework may rely on approvals from recognized international agencies. Without explicit confirmation, the approval status remains uncertain.
Regulatory body: St. Lucia National Regulatory Authority
Last updated: May 22, 2025
Liechtenstein
Approved
Repatha is approved in Liechtenstein through the European Medicines Agency (EMA) centralized procedure, allowing its marketing authorization across the European Economic Area. The approval covers treatment of hypercholesterolemia and prevention of cardiovascular events under specified conditions. It is regulated in line with EU pharmaceutical standards.
Regulatory body: European Medicines Agency (EMA)
Last updated: May 22, 2025
Sri Lanka
Approved
Repatha is approved in Sri Lanka by the National Medicines Regulatory Authority (NMRA). The approval allows its use for patients with elevated LDL cholesterol levels who are at high cardiovascular risk. The NMRA's decision was based on international clinical evidence and regulatory approvals from stringent authorities.
Regulatory body: NMRA
Last updated: May 22, 2025
Liberia
Not Approved
Repatha's approval status in Liberia is not well documented in publicly accessible regulatory databases. The Liberia Medicines and Health Products Regulatory Authority has not released specific information regarding this product. Healthcare providers should verify availability through official channels.
Regulatory body: Liberia National Regulatory Authority
Last updated: May 22, 2025
Lesotho
Not Approved
There is limited publicly available information regarding the regulatory status of Repatha in Lesotho. The national regulatory authority has not issued clear guidance or approval announcements for this medicine. Further inquiry with local health authorities is recommended to confirm its status.
Regulatory body: Lesotho National Regulatory Authority
Last updated: May 22, 2025
Lithuania
Approved
Repatha has received marketing authorization in Lithuania via the European Medicines Agency (EMA) centralized approval process. The State Medicines Control Agency of Lithuania oversees its distribution and ensures compliance with EU regulations. The medicine is indicated for patients with high cholesterol and cardiovascular risk.
Regulatory body: European Medicines Agency (EMA)
Last updated: May 22, 2025
Luxembourg
Approved
Repatha is authorized for use in Luxembourg following approval by the European Medicines Agency (EMA). The Luxembourg Ministry of Health enforces EMA guidelines and ensures the medicine is available for indicated cardiovascular conditions. Prescribing is restricted to specialists in accordance with approved indications.
Regulatory body: European Medicines Agency (EMA)
Last updated: May 22, 2025
Latvia
Approved
Repatha is approved in Latvia under the European Medicines Agency (EMA) centralized procedure, allowing its use across EU member states. The State Agency of Medicines in Latvia regulates its distribution and use for patients with hypercholesterolemia and cardiovascular risk. It is available by prescription with adherence to EMA-approved indications.
Regulatory body: EMA
Last updated: May 22, 2025
Libya
Not Approved
There is no clear evidence of regulatory approval for Repatha by the Libyan National Centre for Drug Control and Research. Due to limited regulatory transparency, the approval status remains uncertain. Patients and healthcare professionals should consult local authorities for the most current information.
Regulatory body: Libya National Regulatory Authority
Last updated: May 22, 2025
Morocco
Approved
Repatha is approved in Morocco by the Ministry of Health's Directorate of Medicines and Pharmacy. The approval is granted for treatment of patients with hypercholesterolemia who require additional LDL cholesterol lowering beyond standard therapy. The regulatory decision aligns with international clinical guidelines.
Regulatory body: Ministry of Health - Directorate of Medicines and Pharmacy
Last updated: May 22, 2025
Monaco
Approved
Repatha is approved for use in Monaco, with regulatory oversight provided by the Monaco Directorate of Health in alignment with European Medicines Agency (EMA) standards. The approval covers treatment of adults with primary hypercholesterolemia or mixed dyslipidemia. Access is generally consistent with EU member state practices.
Regulatory body: Monaco Directorate of Health
Last updated: May 22, 2025
Moldova
Approved
Repatha has been approved in Moldova by the State Agency for Medicines and Medical Devices. The approval follows evaluation of clinical data supporting its efficacy in lowering LDL cholesterol in patients with hypercholesterolemia. Usage is subject to local prescribing guidelines and reimbursement policies.
Regulatory body: State Agency for Medicines and Medical Devices
Last updated: May 22, 2025
Montenegro
Approved
Repatha has received approval from the Agency for Medicines and Medical Devices of Montenegro. The approval is based on clinical trial data demonstrating its efficacy and safety in reducing LDL cholesterol levels in patients with familial hypercholesterolemia and atherosclerotic cardiovascular disease. Prescribing is subject to national reimbursement criteria.
Regulatory body: Agency for Medicines and Medical Devices of Montenegro
Last updated: May 22, 2025
St. Martin
Not Approved
As a French overseas collectivity, St. Martin generally follows the regulatory decisions of the European Medicines Agency (EMA). While Repatha is approved by the EMA, specific local registration details for St. Martin are not explicitly available. It is reasonable to infer availability, but formal local approval documentation is not confirmed.
Regulatory body: St. Martin National Regulatory Authority
Last updated: May 22, 2025
Madagascar
Not Approved
There is no accessible information confirming the approval of Repatha by Madagascar's Ministry of Public Health. The regulatory framework in Madagascar does not provide clear public records regarding this medicine. Healthcare providers should consult local authorities for updated information.
Regulatory body: Madagascar National Regulatory Authority
Last updated: May 22, 2025
Marshall Islands
Not Approved
There is no clear publicly available information regarding the approval status of Repatha in the Marshall Islands. The country relies on approvals from larger regulatory bodies or regional agreements, but specific approval by local authorities has not been documented. The status remains unknown.
Regulatory body: Marshall Islands National Regulatory Authority
Last updated: May 22, 2025
North Macedonia
Approved
Repatha has received approval from the Macedonian Agency for Medicines and Medical Devices (MALMED) for use in patients with hypercholesterolemia and cardiovascular risk. The approval aligns with European Medicines Agency (EMA) guidelines, enabling its prescription under specified clinical conditions.
Regulatory body: MALMED
Last updated: May 22, 2025
Mali
Not Approved
The regulatory status of Repatha in Mali is not well documented in publicly accessible sources. The Agence Nationale de la Pharmacie et du Médicament (ANPM) has not provided explicit information regarding approval. Consequently, the approval status is currently unknown and may depend on regional regulatory harmonization efforts.
Regulatory body: Mali National Regulatory Authority
Last updated: May 22, 2025
Myanmar (Burma)
Not Approved
The approval status of Repatha in Myanmar is not publicly documented. The Food and Drug Administration of Myanmar has limited publicly available data on biologic drug approvals, and therefore the status of Repatha remains unknown. Access may be restricted or limited to special importation.
Regulatory body: FDA
Last updated: May 22, 2025
Mongolia
Not Approved
There is limited information available regarding the approval status of Repatha in Mongolia. The Mongolian Medicines Regulatory Agency has not publicly disclosed specific approvals for this biologic agent. Consequently, the approval status remains unknown at this time.
Regulatory body: Mongolia National Regulatory Authority
Last updated: May 22, 2025
Macao SAR China
Not Approved
The regulatory status of Repatha in Macao SAR China is not publicly documented. The Health Bureau of Macao has not released specific approval information for this medicine. Further confirmation from local regulatory authorities is advised for accurate status verification.
Regulatory body: Macao SAR China National Regulatory Authority
Last updated: May 22, 2025
Northern Mariana Islands
Approved
Repatha is considered approved in the Northern Mariana Islands as it follows the regulatory approvals of the United States Food and Drug Administration (FDA). Since the Northern Mariana Islands is a US commonwealth, FDA approvals apply directly, allowing Repatha to be marketed and prescribed under the same conditions as in the US.
Regulatory body: FDA
Last updated: May 22, 2025
Martinique
Approved
As an overseas region of France, Martinique follows the European Medicines Agency (EMA) approvals. Repatha is authorized for use in Martinique under EMA regulations for the treatment of hypercholesterolemia and prevention of cardiovascular events. The medicine is available through prescription consistent with EU standards.
Regulatory body: EMA
Last updated: May 22, 2025
Mauritania
Not Approved
Mauritania's regulatory authority has not publicly disclosed the approval status of Repatha. The Agence Nationale de Réglementation Pharmaceutique (ANRP) may not have processed or published information regarding this medicine. Thus, the approval status is currently unknown.
Regulatory body: Mauritania National Regulatory Authority
Last updated: May 22, 2025
Montserrat
Not Approved
Montserrat does not have a well-established independent pharmaceutical regulatory authority, and there is no publicly available data on the approval status of Repatha. Medicines are typically regulated under broader UK or regional frameworks, making the specific approval status unknown.
Regulatory body: Montserrat National Regulatory Authority
Last updated: May 22, 2025
Malta
Approved
Repatha is approved in Malta through the centralized European Medicines Agency (EMA) authorization process. The Malta Medicines Authority recognizes EMA approvals, and Repatha is authorized for use in patients requiring LDL cholesterol reduction. Its availability is consistent with EU regulatory standards and guidelines.
Regulatory body: EMA
Last updated: May 22, 2025
Mauritius
Approved
Repatha has been approved by the Mauritius Pharmacy Board for clinical use in managing high cholesterol and reducing cardiovascular risk. The approval followed evaluation of clinical data and aligns with international regulatory standards. It is available by prescription with appropriate medical oversight.
Regulatory body: Mauritius Pharmacy Board
Last updated: May 22, 2025
Maldives
Not Approved
There is limited publicly available information regarding the regulatory status of Repatha in the Maldives. The Maldives Food and Drug Authority (MFDA) has not published clear data on the approval or rejection of this medicine. Therefore, the approval status remains uncertain and may require direct inquiry with local authorities.
Regulatory body: FDA
Last updated: May 22, 2025
Malawi
Not Approved
Repatha's approval status in Malawi remains unclear due to lack of publicly available data from the Pharmacy, Medicines and Poisons Board of Malawi. No official announcements or registrations have been identified. Verification with local regulatory bodies is recommended for confirmation.
Regulatory body: Malawi National Regulatory Authority
Last updated: May 22, 2025
Mexico
Approved
Repatha is approved by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) for the treatment of hypercholesterolemia and cardiovascular risk reduction. The approval is based on comprehensive clinical trial data and aligns with international standards. It is available by prescription with defined therapeutic indications.
Regulatory body: COFEPRIS
Last updated: May 22, 2025
Malaysia
Approved
Repatha (evolocumab) is approved by the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia for use in patients with hyperlipidemia and for the prevention of cardiovascular events. The approval was granted following a thorough review of clinical trial data demonstrating its efficacy and safety profile. It is available under prescription with specific indications aligned with international guidelines.
Regulatory body: NPRA
Last updated: May 22, 2025
Mozambique
Not Approved
There is no accessible information regarding the regulatory approval of Repatha in Mozambique. The National Directorate of Pharmacy and Medicines has not publicly confirmed approval status, and the medicine's availability may be limited. Thus, the approval status is considered unknown.
Regulatory body: Mozambique National Regulatory Authority
Last updated: May 22, 2025
Namibia
Approved
Repatha has been approved in Namibia by the Namibia Medicines Regulatory Council. The approval is based on comprehensive clinical evidence supporting its use in lowering LDL cholesterol in patients with familial hypercholesterolemia and cardiovascular risk. Prescribing is regulated and subject to national treatment guidelines.
Regulatory body: Namibia Medicines Regulatory Council
Last updated: May 22, 2025
New Caledonia
Not Approved
New Caledonia follows French regulatory standards through the French National Agency for Medicines and Health Products Safety (ANSM). However, specific information about Repatha's approval status in New Caledonia is not explicitly available. It is likely that access is governed by French regulations, but local availability may be subject to additional administrative procedures.
Regulatory body: New Caledonia National Regulatory Authority
Last updated: May 22, 2025
Niger
Not Approved
The regulatory approval status of Repatha in Niger is not documented in accessible international pharmaceutical databases. Niger's National Directorate of Pharmacy and Medicines oversees drug approvals, but no specific information confirms Repatha's registration. Access may be limited or managed through importation channels.
Regulatory body: Niger National Regulatory Authority
Last updated: May 22, 2025
Norfolk Island
Not Approved
Norfolk Island is an external territory of Australia and generally follows the Therapeutic Goods Administration (TGA) regulations. However, there is no explicit information confirming Repatha's approval status specifically for Norfolk Island. Access to the medicine is likely governed by Australian regulatory approvals and importation policies.
Regulatory body: TGA
Last updated: May 22, 2025
Nigeria
Approved
Repatha has been approved by the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria. The approval covers its use for lowering LDL cholesterol in patients with hypercholesterolemia and those at high cardiovascular risk. This approval follows evaluation of clinical evidence and aligns with global regulatory standards.
Regulatory body: NAFDAC
Last updated: May 22, 2025
Nicaragua
Not Approved
There is no clear publicly available information regarding the approval of Repatha by the Nicaraguan Ministry of Health (MINSA). The regulatory framework in Nicaragua may not have specific records accessible internationally, making the approval status uncertain. Healthcare providers should consult local regulatory authorities for confirmation.
Regulatory body: Nicaragua National Regulatory Authority
Last updated: May 22, 2025
Netherlands
Approved
Repatha is approved in the Netherlands by the Medicines Evaluation Board (CBG-MEB), which operates under the European Medicines Agency (EMA) framework. It is authorized for use in patients with hypercholesterolemia and those at high cardiovascular risk who require additional LDL cholesterol lowering. The approval follows comprehensive clinical data demonstrating efficacy and safety.
Regulatory body: CBG-MEB
Last updated: May 22, 2025
Norway
Approved
Repatha is approved by the Norwegian Medicines Agency (NoMA) and is available for treatment of patients with high cholesterol who require additional LDL-C lowering beyond standard therapy. The approval follows the European Medicines Agency's (EMA) authorization and includes specific indications for familial hypercholesterolemia and atherosclerotic cardiovascular disease.
Regulatory body: NoMA
Last updated: May 22, 2025
Nepal
Not Approved
Repatha's approval status in Nepal is not well documented in publicly accessible regulatory databases. The Department of Drug Administration (DDA) is the regulatory authority in Nepal, but there is no clear record of Repatha's formal approval. Healthcare providers may need to verify availability through local importers or special access schemes.
Regulatory body: Nepal National Regulatory Authority
Last updated: May 22, 2025
Nauru
Not Approved
There is limited publicly available information regarding the regulatory approval status of Repatha in Nauru. Given the small size and limited pharmaceutical regulatory infrastructure, it is unclear if Repatha has been formally approved or registered by any local authority. Patients and healthcare providers may need to rely on approvals from larger regulatory bodies or importation under special access provisions.
Regulatory body: Nauru National Regulatory Authority
Last updated: May 22, 2025
Niue
Not Approved
Niue does not have a formal pharmaceutical regulatory authority and typically relies on approvals from New Zealand and other larger jurisdictions. There is no specific record of Repatha approval in Niue, and access is likely dependent on importation under New Zealand regulations or special access programs.
Regulatory body: Niue National Regulatory Authority
Last updated: May 22, 2025
New Zealand
Approved
Repatha is approved by Medsafe, New Zealand's medicines and medical devices safety authority. It is indicated for patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease requiring further LDL cholesterol reduction. The approval is based on robust clinical trial data and aligns with international regulatory standards.
Regulatory body: Medsafe
Last updated: May 22, 2025
Oman
Approved
Repatha has been approved by the Oman Ministry of Health for use in patients with hyperlipidemia and cardiovascular risk factors. The approval is based on clinical data supporting its efficacy and safety, and it is available through authorized healthcare providers and pharmacies within Oman.
Regulatory body: Oman Ministry of Health
Last updated: May 22, 2025
Panama
Approved
Repatha is approved by Panama's Ministry of Health (MINSA) for use in patients with high cholesterol and cardiovascular disease risk. The approval follows international standards and allows for its prescription under defined clinical guidelines within Panama.
Regulatory body: MINSA
Last updated: May 22, 2025
Peru
Approved
Repatha is approved in Peru by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). It is authorized for use in patients with familial hypercholesterolemia and those with atherosclerotic cardiovascular disease requiring further LDL-cholesterol reduction. The approval was granted after review of clinical trial data demonstrating its benefit and safety profile.
Regulatory body: DIGEMID
Last updated: May 22, 2025
French Polynesia
Approved
Repatha is approved in French Polynesia under the regulatory oversight of the French National Agency for the Safety of Medicines and Health Products (ANSM). As an overseas collectivity of France, French Polynesia adheres to French pharmaceutical regulations, enabling access to Repatha for indicated patients. Distribution and reimbursement follow French healthcare frameworks.
Regulatory body: ANSM
Last updated: May 22, 2025
Papua New Guinea
Not Approved
There is limited information regarding the approval status of Repatha in Papua New Guinea. The country's pharmaceutical regulatory framework is developing, and no clear records indicate formal approval or availability of Repatha at this time.
Regulatory body: Papua New Guinea National Regulatory Authority
Last updated: May 22, 2025
Philippines
Approved
The Philippine Food and Drug Administration (FDA) has approved Repatha for the treatment of patients with hyperlipidemia and cardiovascular disease at high risk. The approval includes its use as an adjunct to diet and maximally tolerated statin therapy. Regulatory evaluation confirmed the drug's efficacy and safety consistent with global clinical evidence.
Regulatory body: Philippine FDA
Last updated: May 22, 2025
Pakistan
Approved
Repatha is approved by the Drug Regulatory Authority of Pakistan (DRAP) for the treatment of patients with familial hypercholesterolemia and those requiring additional LDL cholesterol reduction. The approval includes conditions consistent with international guidelines and allows its availability in the Pakistani pharmaceutical market.
Regulatory body: DRAP
Last updated: May 22, 2025
Poland
Approved
Repatha has been approved in Poland by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). It is indicated for patients with primary hypercholesterolemia or mixed dyslipidemia and those with cardiovascular disease requiring additional LDL-cholesterol lowering. The approval is aligned with European Medicines Agency (EMA) guidelines.
Regulatory body: URPL
Last updated: May 22, 2025
St. Pierre & Miquelon
Not Approved
St. Pierre & Miquelon, as a French territorial collectivity, typically adheres to EMA approvals for pharmaceuticals. Repatha is approved by the EMA; however, explicit local approval records for St. Pierre & Miquelon are not publicly detailed. Access is likely aligned with EMA regulations.
Regulatory body: St. Pierre & Miquelon National Regulatory Authority
Last updated: May 22, 2025
Pitcairn Islands
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in the Pitcairn Islands. Given the territory's small population and limited local regulatory infrastructure, medicines are typically accessed through New Zealand or other jurisdictions. Therefore, the approval status remains unknown.
Regulatory body: Pitcairn Islands National Regulatory Authority
Last updated: May 22, 2025
Palestinian Territories
Not Approved
The regulatory approval status of Repatha in the Palestinian Territories is not well documented. Due to the complex regulatory environment and limited formal pharmaceutical approval processes, it is uncertain whether Repatha is officially approved or available.
Regulatory body: Palestinian Territories National Regulatory Authority
Last updated: May 22, 2025
Portugal
Approved
Repatha is authorized for use in Portugal by Infarmed, the national authority for medicines and health products. The approval covers its indication for lowering LDL cholesterol in patients with familial hypercholesterolemia and established cardiovascular disease. Infarmed's approval is consistent with the European Medicines Agency's centralized authorization.
Regulatory body: Infarmed
Last updated: May 22, 2025
Palau
Not Approved
There is no publicly accessible information regarding the regulatory status of Repatha in Palau. Given the limited pharmaceutical regulatory infrastructure and market size, the approval status remains unclear and may depend on importation under special provisions.
Regulatory body: Palau National Regulatory Authority
Last updated: May 22, 2025
Paraguay
Approved
Repatha (evolocumab) has been approved by the Paraguayan regulatory authority, the Dirección Nacional de Vigilancia Sanitaria (DINAVISA). The approval allows its use for patients with hypercholesterolemia and cardiovascular risk who require additional LDL-cholesterol lowering beyond standard therapy. The approval follows evaluation of clinical efficacy and safety data consistent with international standards.
Regulatory body: DINAVISA
Last updated: May 22, 2025
Qatar
Approved
The Qatar Ministry of Public Health has approved Repatha for clinical use in patients with hypercholesterolemia and cardiovascular risk. The approval followed submission of comprehensive clinical data demonstrating efficacy and safety. Repatha is available through hospital pharmacies and specialist clinics under regulatory oversight.
Regulatory body: Qatar Ministry of Public Health
Last updated: May 22, 2025
Réunion
Approved
As an overseas department of France, Réunion follows the European Medicines Agency (EMA) centralized approvals. Repatha is approved for use in Réunion under the authorization granted by EMA and implemented by the French National Agency for Medicines and Health Products Safety (ANSM). It is indicated for patients requiring additional LDL-cholesterol lowering.
Regulatory body: EMA / ANSM
Last updated: May 22, 2025
Romania
Approved
Repatha is approved in Romania by the National Agency for Medicines and Medical Devices (ANMDM). It is indicated for patients with familial hypercholesterolemia and those with cardiovascular disease needing further LDL-cholesterol reduction. The approval aligns with EMA recommendations and includes reimbursement under certain clinical criteria.
Regulatory body: ANMDM
Last updated: May 22, 2025
Serbia
Approved
Repatha is approved by the Medicines and Medical Devices Agency of Serbia (ALIMS) for use in patients with high cholesterol and cardiovascular risk. The approval aligns with European regulatory standards, allowing its prescription under specified clinical indications.
Regulatory body: ALIMS
Last updated: May 22, 2025
Russia
Approved
Repatha has received marketing authorization from the Russian Ministry of Health for the treatment of hypercholesterolemia and prevention of cardiovascular events. The approval is based on clinical data demonstrating its efficacy and safety in the Russian population. It is available through prescription with specific indications outlined by the regulatory authority.
Regulatory body: Russian Ministry of Health
Last updated: May 22, 2025
Rwanda
Not Approved
There is no publicly available information confirming the regulatory approval status of Repatha by the Rwanda Food and Drugs Authority (RFDA). Given Rwanda's evolving pharmaceutical regulatory environment, it is recommended to consult local regulatory sources for the most current status.
Regulatory body: FDA
Last updated: May 22, 2025
Saudi Arabia
Approved
Repatha has been approved by the Saudi Food and Drug Authority (SFDA) for the treatment of hypercholesterolemia and prevention of cardiovascular events. The SFDA approval follows rigorous evaluation of clinical data, and the medicine is available under prescription with specific indications consistent with international guidelines.
Regulatory body: SFDA
Last updated: May 22, 2025
Solomon Islands
Not Approved
There is no publicly available information regarding the regulatory approval status of Repatha in the Solomon Islands. The country has limited local pharmaceutical regulatory infrastructure, and medicines are often imported under special access or WHO prequalification programs. Therefore, the approval status remains unclear.
Regulatory body: Solomon Islands National Regulatory Authority
Last updated: May 22, 2025
Seychelles
Not Approved
There is no publicly available information confirming the approval of Repatha by the Seychelles Medicines Agency. Due to the limited pharmaceutical regulatory infrastructure, the approval status remains uncertain.
Regulatory body: Seychelles National Regulatory Authority
Last updated: May 22, 2025
Sudan
Not Approved
The approval status of Repatha in Sudan is not clearly documented in accessible regulatory databases. Sudan’s National Medicines and Poisons Board is responsible for approvals, but no explicit confirmation regarding Repatha is available. The medicine’s availability may be limited or subject to importation under special permissions.
Regulatory body: Sudan National Regulatory Authority
Last updated: May 22, 2025
Sweden
Approved
Repatha is approved in Sweden by the Medical Products Agency (Läkemedelsverket), following its authorization by the European Medicines Agency (EMA). The approval covers the treatment of hypercholesterolemia and prevention of cardiovascular events in specific patient populations. Sweden adheres to EMA guidelines ensuring the medicine’s availability under prescribed conditions.
Regulatory body: Medical Products Agency (Läkemedelsverket)
Last updated: May 22, 2025
Singapore
Approved
Repatha is approved by the Health Sciences Authority (HSA) of Singapore for the treatment of hyperlipidemia and prevention of cardiovascular events. The approval is based on comprehensive clinical trial data and aligns with international regulatory standards, making it available through prescription.
Regulatory body: HSA
Last updated: May 22, 2025
St. Helena
Not Approved
There is limited publicly available information regarding the regulatory approval status of Repatha in St. Helena. Given the small size and limited pharmaceutical regulatory infrastructure of the territory, it is unclear whether Repatha has been formally approved or registered for use. Healthcare providers may rely on approvals from larger regulatory bodies for guidance.
Regulatory body: St. Helena National Regulatory Authority
Last updated: May 22, 2025
Slovenia
Approved
Repatha has been approved in Slovenia by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). This approval follows the EMA's centralized authorization, permitting its use for patients with high cholesterol who require additional LDL cholesterol lowering. Usage is subject to national reimbursement policies and clinical criteria.
Regulatory body: JAZMP
Last updated: May 22, 2025
Svalbard & Jan Mayen
Not Approved
Svalbard & Jan Mayen are territories under Norwegian sovereignty, and pharmaceutical approvals are governed by the Norwegian Medicines Agency in line with European regulations. While Repatha is approved by the EMA and Norwegian authorities, specific documentation for these territories is not separately maintained. Access is presumed consistent with Norway.
Regulatory body: Svalbard & Jan Mayen National Regulatory Authority
Last updated: May 22, 2025
Slovakia
Approved
Repatha is approved in Slovakia by the State Institute for Drug Control (ŠÚKL). The approval aligns with the European Medicines Agency (EMA) authorization, allowing its use for lowering LDL cholesterol in patients with hypercholesterolemia and cardiovascular risk. Repatha is available under specific clinical guidelines and reimbursement conditions set by Slovak health authorities.
Regulatory body: ŠÚKL
Last updated: May 22, 2025
Sierra Leone
Not Approved
Repatha's regulatory approval status in Sierra Leone is not documented in accessible public records. The Pharmacy Board of Sierra Leone has not published information confirming its approval or availability.
Regulatory body: Sierra Leone National Regulatory Authority
Last updated: May 22, 2025
San Marino
Approved
Repatha is approved in San Marino through the regulatory framework aligned with the European Medicines Agency (EMA). As San Marino often follows EMA decisions, Repatha is available for use under the conditions authorized by the EMA, primarily for lowering LDL cholesterol in patients at high cardiovascular risk.
Regulatory body: EMA
Last updated: May 22, 2025
Senegal
Not Approved
The approval status of Repatha in Senegal is not publicly documented. Senegal’s regulatory authority, the Directorate of Pharmacy and Medicines, has limited accessible data on this product, and no confirmation of approval is currently available.
Regulatory body: Senegal National Regulatory Authority
Last updated: May 22, 2025
Somalia
Not Approved
Repatha's regulatory approval status in Somalia is unknown due to the absence of a formal national regulatory authority with publicly accessible records. The healthcare system relies heavily on international aid and imported medicines under special arrangements. Consequently, no definitive approval information is available.
Regulatory body: Somalia National Regulatory Authority
Last updated: May 22, 2025
Suriname
Not Approved
There is no definitive public information on the approval of Repatha by Suriname’s Medicines and Food Board. The regulatory environment in Suriname may depend on approvals from larger agencies, but local registration status for Repatha remains unconfirmed. Patients should consult local health authorities for guidance.
Regulatory body: Suriname National Regulatory Authority
Last updated: May 22, 2025
São Tomé & Príncipe
Not Approved
There is no clear regulatory information available regarding the approval of Repatha in São Tomé & Príncipe. The country’s regulatory infrastructure for pharmaceuticals is limited, and no public records confirm its approval status.
Regulatory body: São Tomé & Príncipe National Regulatory Authority
Last updated: May 22, 2025
El Salvador
Not Approved
There is no publicly available confirmation regarding the approval status of Repatha in El Salvador. The country’s regulatory agency has limited published data on biologic approvals. Healthcare providers should consult the Ministry of Health for up-to-date information on availability and authorization.
Regulatory body: El Salvador National Regulatory Authority
Last updated: May 22, 2025
Syria
Not Approved
There is limited publicly available information regarding the regulatory approval status of Repatha in Syria. The national regulatory authority's decisions on this medicine are not well documented internationally, making it difficult to confirm its approval or availability in the Syrian market.
Regulatory body: Syria National Regulatory Authority
Last updated: May 22, 2025
Eswatini
Not Approved
The regulatory approval status of Repatha in Eswatini is not publicly available. Eswatini’s Medicines Regulatory Authority has limited published data on biologic drug approvals. It is recommended to consult local health authorities for the most current information on Repatha’s authorization.
Regulatory body: Eswatini National Regulatory Authority
Last updated: May 22, 2025
Turks & Caicos Islands
Not Approved
The Turks & Caicos Islands do not maintain a widely accessible public registry for pharmaceutical approvals, and there is no clear evidence of Repatha's approval in this jurisdiction. Regulatory oversight is limited and often aligned with broader UK or Caribbean regional standards. Direct consultation with local health authorities is recommended.
Regulatory body: Turks & Caicos Islands National Regulatory Authority
Last updated: May 22, 2025
Chad
Not Approved
There is no clear public record of Repatha's approval status in Chad. The national regulatory framework for pharmaceuticals is still developing, and specific approvals for advanced biologic treatments like Repatha are not well documented. Healthcare professionals should verify with the Ministry of Public Health for current status.
Regulatory body: Chad National Regulatory Authority
Last updated: May 22, 2025
French Southern Territories
Not Approved
The French Southern Territories have no permanent population and limited healthcare infrastructure; thus, there is no specific regulatory approval status for Repatha. Regulatory oversight is nominally under French authorities, but practical approval and distribution information is not available. The approval status is considered unknown.
Last updated: May 22, 2025
Togo
Not Approved
The regulatory status of Repatha in Togo is not well documented in publicly accessible sources. The national regulatory authority's decisions on this product remain unclear, resulting in an unknown approval status.
Regulatory body: Togo National Regulatory Authority
Last updated: May 22, 2025
Thailand
Approved
The Thai Food and Drug Administration (Thai FDA) has approved Repatha for the treatment of hypercholesterolemia and prevention of cardiovascular disease in high-risk patients. The approval was granted after thorough review of clinical efficacy and safety data. The Thai FDA regulates its use under standard pharmaceutical guidelines.
Regulatory body: Thai FDA
Last updated: May 22, 2025
Tajikistan
Not Approved
There is no clear publicly accessible information regarding the approval status of Repatha in Tajikistan. The regulatory framework and decisions of the Tajikistan Ministry of Health concerning this medicine are not widely reported, leaving its approval status uncertain.
Regulatory body: Tajikistan National Regulatory Authority
Last updated: May 22, 2025
Tokelau
Not Approved
Tokelau does not have an independent pharmaceutical regulatory authority, and medicines are generally supplied through New Zealand's regulatory framework. There is no specific approval status for Repatha in Tokelau, making its availability and regulatory status unknown.
Regulatory body: Tokelau National Regulatory Authority
Last updated: May 22, 2025
Timor-Leste
Not Approved
There is insufficient information available regarding the regulatory approval of Repatha in Timor-Leste. The country's regulatory infrastructure for pharmaceuticals is still developing, and no public records confirm the approval or registration of this medicine.
Regulatory body: Timor-Leste National Regulatory Authority
Last updated: May 22, 2025
Turkmenistan
Not Approved
There is no publicly available information confirming the approval status of Repatha in Turkmenistan. The State Service for Pharmaceutical and Medical Industry Control is responsible for drug approvals, but no records indicate Repatha's registration. Verification with local regulatory authorities is advised for accurate status.
Regulatory body: Turkmenistan National Regulatory Authority
Last updated: May 22, 2025
Tunisia
Not Approved
The regulatory approval status of Repatha in Tunisia is not clearly documented in accessible regulatory databases. The Tunisian Ministry of Public Health oversees pharmaceutical approvals, but no explicit confirmation of Repatha approval is publicly available. Additional verification from local health authorities is recommended.
Regulatory body: Tunisia National Regulatory Authority
Last updated: May 22, 2025
Tonga
Not Approved
There is no publicly available information regarding the approval of Repatha by Tonga's Ministry of Health or other regulatory bodies. The medicine's status in Tonga remains uncertain due to limited regulatory infrastructure and reporting.
Regulatory body: Tonga National Regulatory Authority
Last updated: May 22, 2025
Türkiye
Approved
Repatha has been approved by the Turkish Medicines and Medical Devices Agency (TİTCK) for the treatment of hypercholesterolemia and cardiovascular risk reduction. The approval aligns with international standards and allows for its prescription under specific clinical guidelines. This facilitates patient access to PCSK9 inhibitor therapy within Turkey.
Regulatory body: TİTCK
Last updated: May 22, 2025
Trinidad & Tobago
Not Approved
There is limited publicly available information regarding the regulatory approval status of Repatha in Trinidad & Tobago. The Health Sciences Authority or equivalent regulatory body has not widely published approval details, making the status unclear. Further inquiry with local regulatory authorities would be necessary to confirm availability.
Regulatory body: HSA
Last updated: May 22, 2025
Tuvalu
Not Approved
Due to Tuvalu's small market size and limited regulatory infrastructure, there is no publicly available information regarding the approval of Repatha. Pharmaceuticals are often imported under special arrangements, and formal approval status remains unclear. Local health officials or regional regulatory bodies may provide further guidance.
Regulatory body: Tuvalu National Regulatory Authority
Last updated: May 22, 2025
Taiwan, Province of China
Approved
Repatha has been approved by Taiwan's Food and Drug Administration (TFDA) for use in patients with hyperlipidemia and those at high risk of cardiovascular events. The approval followed comprehensive evaluation of clinical trial data and aligns with international regulatory standards. The TFDA continues to oversee its safety and efficacy post-approval.
Regulatory body: TFDA
Last updated: May 22, 2025
Tanzania
Not Approved
Repatha is not currently approved by the Tanzania Medicines and Medical Devices Authority (TMDA). The medicine has not been registered for use in Tanzania, and there is no indication that it is available through formal regulatory channels. Patients requiring this treatment may need to explore alternative options.
Last updated: May 22, 2025
Ukraine
Approved
Repatha has received approval from the State Expert Center of the Ministry of Health of Ukraine for use in patients with hypercholesterolemia and atherosclerotic cardiovascular disease. The approval includes indications consistent with international guidelines for PCSK9 inhibitors. This facilitates its clinical use within Ukraine under regulated conditions.
Regulatory body: State Expert Center of the Ministry of Health of Ukraine
Last updated: May 22, 2025
Uganda
Not Approved
Repatha's approval status in Uganda is not clearly documented in publicly accessible regulatory databases. The National Drug Authority (NDA) regulates medicines, but no explicit information confirms Repatha's registration. Patients and healthcare providers should consult the NDA for the most current information.
Regulatory body: Uganda National Regulatory Authority
Last updated: May 22, 2025
U.S. Outlying Islands
Approved
As a territory under US jurisdiction, the U.S. Outlying Islands follow the regulatory approvals granted by the US FDA. Therefore, Repatha is considered approved for use in these territories under the same conditions as in the continental United States. Distribution and prescription are governed by FDA regulations applicable to these regions.
Regulatory body: FDA
Last updated: May 22, 2025
United States
Approved
Repatha (evolocumab) is approved by the US Food and Drug Administration (FDA) for the treatment of high cholesterol, specifically for patients with familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease. The FDA approval was based on clinical trials demonstrating significant LDL cholesterol reduction and cardiovascular risk mitigation. It is available by prescription and used as an adjunct to diet and maximally tolerated statin therapy.
Regulatory body: FDA
Last updated: May 22, 2025
Uruguay
Approved
Repatha has received approval from Uruguay's Ministry of Public Health (Ministerio de Salud Pública) for use in patients requiring additional LDL cholesterol lowering beyond standard therapies. The approval follows international regulatory precedents and clinical evidence supporting its efficacy and safety. It is accessible through prescription under regulated conditions.
Regulatory body: Ministerio de Salud Pública
Last updated: May 22, 2025
Uzbekistan
Not Approved
There is limited publicly available information regarding the regulatory approval status of Repatha in Uzbekistan. The State Center for Expertise and Standardization of Medicines under the Ministry of Health is the responsible authority, but no clear records indicate formal approval or rejection. Availability and use in Uzbekistan remain uncertain.
Regulatory body: Uzbekistan National Regulatory Authority
Last updated: May 22, 2025
Vatican City
Not Approved
Vatican City does not have an independent pharmaceutical regulatory authority and typically relies on approvals from neighboring countries, primarily Italy and the European Medicines Agency (EMA). There is no specific approval record for Repatha in Vatican City, but it is likely accessible through Italian healthcare channels.
Regulatory body: Vatican City National Regulatory Authority
Last updated: May 22, 2025
St. Vincent & Grenadines
Not Approved
There is no publicly available information confirming the regulatory approval of Repatha in St. Vincent & Grenadines. The country may rely on approvals from larger regulatory authorities, but local registration status remains undocumented. Healthcare professionals should verify with local regulatory bodies.
Regulatory body: St. Vincent & Grenadines National Regulatory Authority
Last updated: May 22, 2025
Venezuela
Not Approved
Due to limited transparency and availability of regulatory information from Venezuela's National Institute of Drug and Food Control (INVIMA), the approval status of Repatha is unclear. Economic and regulatory challenges in the country may affect the availability and formal registration of this medicine.
Regulatory body: Venezuela National Regulatory Authority
Last updated: May 22, 2025
British Virgin Islands
Not Approved
The regulatory approval status of Repatha in the British Virgin Islands is not explicitly documented. Medicines in this territory often rely on approvals from larger regulatory bodies such as the US FDA or EMA for importation and use.
Regulatory body: FDA
Last updated: May 22, 2025
U.S. Virgin Islands
Approved
The U.S. Virgin Islands adhere to the regulatory framework of the US FDA, under which Repatha is approved for the treatment of hypercholesterolemia and cardiovascular risk reduction. The medication is available by prescription and regulated similarly to the mainland United States. Local healthcare providers follow FDA guidelines for its use.
Regulatory body: FDA
Last updated: May 22, 2025
Vietnam
Approved
Repatha has been approved by Vietnam's Ministry of Health for the treatment of patients with hypercholesterolemia and cardiovascular disease risk. The approval was granted following review of clinical data consistent with international standards. It is available through prescription and included in the list of authorized medications in Vietnam.
Regulatory body: Ministry of Health
Last updated: May 22, 2025
Vanuatu
Not Approved
Vanuatu's regulatory framework for pharmaceuticals is managed by the Ministry of Health, but specific data on Repatha's approval status is not publicly accessible. Given the country's limited pharmaceutical regulatory infrastructure, it is unclear whether Repatha is approved, imported, or available through special access programs.
Regulatory body: Vanuatu National Regulatory Authority
Last updated: May 22, 2025
Wallis & Futuna
Not Approved
Wallis & Futuna, as a French overseas collectivity, generally follows the regulatory approvals of the European Medicines Agency (EMA) and French health authorities. However, specific data on the availability or approval of Repatha in this territory is not publicly documented. Access may be possible through French healthcare provisions.
Regulatory body: Wallis & Futuna National Regulatory Authority
Last updated: May 22, 2025
Samoa
Not Approved
Repatha's approval status in Samoa is not documented in accessible regulatory databases. Samoa's Medicines and Medical Devices Regulatory Authority has limited publicly available data on specific pharmaceutical approvals, so the status remains unclear.
Regulatory body: Samoa National Regulatory Authority
Last updated: May 22, 2025
Not Approved
The approval status of Repatha in unspecified or other countries is not determined due to the lack of specific regulatory information. Approval depends on the individual country's regulatory authority and their evaluation processes. Without precise jurisdictional data, the status remains unknown.
Regulatory body: Other National Regulatory Authority
Last updated: May 22, 2025
Yemen
Not Approved
Due to ongoing conflict and instability, Yemen's regulatory environment for pharmaceuticals is severely impacted, and there is no clear information about the approval status of Repatha. The national regulatory authority's capacity to evaluate and approve new medicines is limited, resulting in an unknown status for this medication. Access to innovative therapies like Repatha is likely constrained.
Regulatory body: Yemen National Regulatory Authority
Last updated: May 22, 2025
Mayotte
Approved
Mayotte, as a French overseas department, follows the European Medicines Agency (EMA) approvals. Repatha is authorized for use in Mayotte under EMA regulations for lowering LDL cholesterol and preventing cardiovascular events. The medicine is accessible through prescription consistent with EU regulatory frameworks.
Regulatory body: EMA
Last updated: May 22, 2025
South Africa
Approved
Repatha is approved by the South African Health Products Regulatory Authority (SAHPRA). The approval permits its use for patients with hyperlipidemia and atherosclerotic cardiovascular disease who require additional LDL cholesterol lowering. SAHPRA's authorization follows a thorough review of clinical data supporting efficacy and safety.
Regulatory body: SAHPRA
Last updated: May 22, 2025
Zambia
Approved
Repatha has been approved by the Zambia Medicines Regulatory Authority (ZAMRA) for use in patients with hypercholesterolemia who require additional LDL cholesterol lowering beyond standard therapy. The approval was granted following submission of clinical data demonstrating efficacy and safety consistent with international standards. This approval facilitates access to advanced lipid-lowering therapies within Zambia.
Regulatory body: ZAMRA
Last updated: May 22, 2025
Zimbabwe
Approved
The Medicines Control Authority of Zimbabwe (MCAZ) has approved Repatha for the treatment of patients with familial hypercholesterolemia and those at high cardiovascular risk requiring further LDL cholesterol reduction. The approval was based on comprehensive clinical trial data and aligns with global regulatory decisions. This enables healthcare providers in Zimbabwe to prescribe Repatha under appropriate clinical guidelines.
Regulatory body: MCAZ
Last updated: May 22, 2025
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Repatha – Frequently Asked Questions
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Afghanistan, Albania, Algeria, American Samoa, Angola, Anguilla, Antarctica, Antigua & Barbuda, Armenia, Aruba, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bosnia & Herzegovina, Botswana, Bouvet Island, British Indian Ocean Territory, British Virgin Islands, Brunei, Burkina Faso, Burundi, Cameroon, Cape Verde, Cayman Islands, Central African Republic, Chad, China, Christmas Island, Cocos (Keeling) Islands, Comoros, Congo - Brazzaville, Congo - Kinshasa, Cook Islands, Cuba, Czechia, Côte d’Ivoire, Djibouti, Dominica, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Falkland Islands, Faroe Islands, Fiji, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia, Gibraltar, Greenland, Grenada, Guadeloupe, Guam, Guernsey, Guinea, Guinea-Bissau, Guyana, Haiti, Heard & McDonald Islands, Honduras, Hong Kong SAR China, Hungary, Iceland, Indonesia, Iran, Isle of Man, Jersey, Kazakhstan, Kiribati, Kyrgyzstan, Laos, Lesotho, Liberia, Liechtenstein, Luxembourg, Macao SAR China, Madagascar, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Micronesia, Moldova, Monaco, Mongolia, Montserrat, Morocco, Mozambique, Myanmar (Burma), Namibia, Nauru, New Caledonia, Nicaragua, Niger, Niue, Norfolk Island, North Korea, North Macedonia, Northern Mariana Islands, Palau, Palestinian Territories, Panama, Papua New Guinea, Philippines, Pitcairn Islands, Portugal, Russia, Rwanda, Réunion, Saint Barthélemy, Samoa, San Marino, Senegal, Seychelles, Sierra Leone, Slovakia, Solomon Islands, Somalia, South Africa, South Georgia & South Sandwich Islands, South Korea, St. Helena, St. Kitts & Nevis, St. Lucia, St. Martin, St. Pierre & Miquelon, St. Vincent & Grenadines, Sudan, Suriname, Svalbard & Jan Mayen, Syria, São Tomé & Príncipe, Taiwan, Province of China, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, Turks & Caicos Islands, Tuvalu, U.S. Outlying Islands, U.S. Virgin Islands, Uganda, Ukraine, Uruguay, Uzbekistan, Vanuatu, Vatican City, Vietnam, Wallis & Futuna, Western Sahara, Yemen, Zambia, Åland Islands
We can't ship to:
