European public assessment reports

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This page allows you to find the European public assessment reports (EPAR) for human medicines published by the European Medicines Agency (EMA).

The EMA publishes an EPAR for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). EPARs are full scientific assessment reports of medicines authorised at a European Union level. 

Use this search to find information including a public-friendly summary in question-and-answer format and the package leaflet. You can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.

As of October 2016, EMA publishes the clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure, allowing the public to better understand the Agency’s decision-making. For more information see clinical data publication.

The Agency does not evaluate all medicines currently in use in Europe. If you cannot find the medicine you need through this search, please visit the website of your national health authority.

More information is available on the Central authorisation procedure and in EPARs: background and context.

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EPAR Search results
Name Active substance Therapeutic area Date of authorisation / refusal Additional monitoring Orphan     Has current safety alert Status
Harvoni

ledispavir 90 mg / sofosbuvir 400 mg

Hepatitis C, Chronic 2014-11-17           Authorised
Prandin

repaglinide

Diabetes Mellitus, Type 2 2001-01-29           Authorised
Luminity

perflutren

Echocardiography 2006-09-20           Authorised
Osseor

strontium ranelate

Osteoporosis, Postmenopausal 2004-09-21           Authorised
Natpar

parathyroid hormone

Hypoparathyroidism 2017-04-24           Authorised
Mycophenolate mofetil Teva

mycophenolate mofetil

Graft Rejection 2008-02-21           Authorised
Leflunomide ratiopharm

leflunomide

Arthritis, Rheumatoid 2010-11-29           Authorised
Stivarga

regorafenib

Colorectal Neoplasms 2013-08-26           Authorised
Efavirenz Teva

efavirenz

HIV Infections 2012-01-09           Authorised
Memantine LEK

memantine hydrochloride

Alzheimer Disease 2013-04-22           Authorised
Tasmar

tolcapone

Parkinson Disease 1997-08-27           Authorised
Elocta

efmoroctocog alfa

Hemophilia A 2015-11-19           Authorised
Plegridy

peginterferon beta-1a

Multiple Sclerosis 2014-07-18           Authorised
DaTSCAN

ioflupane (123l)

Alzheimer Disease Lewy Body Disease Parkinson Disease Tomography, Emission-Computed, Single-Photon 2000-07-27           Authorised
Brineura

cerliponase alfa

Neuronal Ceroid-Lipofuscinoses 2017-05-30           Authorised
Entacapone Teva

entacapone

Parkinson Disease 2011-02-18           Authorised
Kivexa

abacavir / lamivudine

HIV Infections 2004-12-17           Authorised
Optison

perflutren

Echocardiography 1998-05-18           Authorised
Yttriga

yttrium [90Y] chloride

Radionuclide Imaging 2006-01-19           Authorised
Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)

clopidogrel / acetylsalicylic acid

Acute Coronary Syndrome Myocardial Infarction 2010-03-15           Authorised
Extavia

interferon beta-1b

Multiple Sclerosis 2008-05-20           Authorised
Invega

paliperidone

Psychotic Disorders Schizophrenia 2007-06-25           Authorised
Foscan

temoporfin

Carcinoma, Squamous Cell Head and Neck Neoplasms 2001-10-24           Authorised
Onivyde

irinotecan hydrochloride trihydrate

Pancreatic Neoplasms 2016-10-14           Authorised
Simbrinza

brinzolamide / brimonidine tartrate

Glaucoma, Open-Angle Ocular Hypertension 2014-07-18           Authorised