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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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
Valdoxan

agomelatine

Depressive Disorder, Major 2009-02-19           Authorised
Zerit

stavudine

HIV Infections 1996-05-08           Authorised
Mekinist

trametinib

Melanoma 2014-06-30           Authorised
Ikervis

ciclosporin

Corneal Diseases 2015-03-19           Authorised
Ammonaps

sodium phenylbutyrate

Carbamoyl-Phosphate Synthase I Deficiency Disease Citrullinemia Ornithine Carbamoyltransferase Deficiency Disease 1999-12-08           Authorised
Capecitabine Accord

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2012-04-20           Authorised
Fiasp

insulin aspart

Diabetes Mellitus 2017-01-09           Authorised
Mvasi

bevacizumab

Breast Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms 2018-01-15           Authorised
Revestive

teduglutide

Malabsorption Syndromes 2012-08-30           Authorised
Cystadane

betaine anhydrous

Homocystinuria 2007-02-15           Authorised
DepoCyte

cytarabine

Meningeal Neoplasms 2001-07-11           Authorised
Axura

memantine hydrochloride

Alzheimer Disease 2002-05-17           Authorised
Telmisartan Teva

telmisartan

Hypertension 2010-01-26           Authorised
Adenuric

febuxostat

Gout 2008-04-21           Authorised
Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)

clopidogrel / acetylsalicylic acid

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

tacrolimus

Dermatitis, Atopic 2002-02-28           Authorised
Raloxifene Teva

raloxifene hydrochloride

Osteoporosis, Postmenopausal 2010-04-29           Authorised
Protelos

strontium ranelate

Osteoporosis, Postmenopausal 2004-09-21           Authorised
Armisarte (previously Pemetrexed Actavis)

pemetrexed diacid monohydrate

Carcinoma, Non-Small-Cell Lung Mesothelioma 2016-01-18           Authorised
Ribavirin Teva Pharma B.V.

ribavirin

Hepatitis C, Chronic 2009-07-01           Authorised
BeneFIX

nonacog alfa

Hemophilia B 1997-08-27           Authorised
Repaglinide Teva

repaglinide

Diabetes Mellitus, Type 2 2009-06-29           Authorised
Zostavax

varicella-zoster virus (live, attenuated)

Herpes Zoster Immunization 2006-05-19           Authorised
Olanzapine Teva

olanzapine

Bipolar Disorder Schizophrenia 2007-12-12           Authorised
Vectibix

panitumumab

Colorectal Neoplasms 2007-12-03           Authorised