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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

telmisartan / hydrochlorothiazide

Hypertension 2002-04-22           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
Lumark

lutetium, isotope of mass 177

Radionuclide Imaging 2015-06-19           Authorised
Adynovi

rurioctocog alfa pegol

Hemophilia A 2018-01-08           Authorised
Telmisartan Teva

telmisartan

Hypertension 2010-01-26           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
Myfenax

mycophenolate mofetil

Graft Rejection 2008-02-21           Authorised
Edarbi

azilsartan medoxomil

Hypertension 2011-12-07           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
Neulasta

pegfilgrastim

Cancer Neutropenia 2002-08-22           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
Topotecan Teva

topotecan

Ovarian Neoplasms Small Cell Lung Carcinoma Uterine Cervical Neoplasms 2009-09-21           Authorised