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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

tacrolimus

Graft Rejection 2007-04-23           Authorised
Litak

cladribine

Leukemia, Hairy Cell 2004-04-14           Authorised
Ifirmasta (previously Irbesartan Krka)

irbesartan hydrochloride

Hypertension 2008-12-01           Authorised
Evicel

human fibrinogen / human thrombin

Hemostasis, Surgical 2008-10-06           Authorised
Karvezide

irbesartan / hydrochlorothiazide

Hypertension 1998-10-16           Authorised
Thorinane

enoxaparin sodium

Venous Thromboembolism 2016-09-15           Authorised
CoAprovel

irbesartan / hydrochlorothiazide

Hypertension 1998-10-15           Authorised
Travatan

travoprost

Glaucoma, Open-Angle Ocular Hypertension 2001-11-27           Authorised
Hepsera

adefovir dipivoxil

Hepatitis B, Chronic 2003-03-06           Authorised
Silodyx

silodosin

Prostatic Hyperplasia 2010-01-29           Authorised
Busulfan Fresenius Kabi

busulfan

Hematopoietic Stem Cell Transplantation 2014-09-22           Authorised
Rasagiline ratiopharm

rasagiline

Parkinson Disease 2015-01-12           Authorised
Prolia

denosumab

Bone Resorption Osteoporosis, Postmenopausal 2010-05-26           Authorised
Clopidogrel Krka d.d. (previously Zopya)

clopidogrel hydrochloride

Myocardial Infarction Peripheral Vascular Diseases Stroke 2009-09-21           Authorised
Izba

travoprost

Glaucoma, Open-Angle Ocular Hypertension 2014-02-20           Authorised
Lysodren

mitotane

Adrenal Cortex Neoplasms 2004-04-28           Authorised
Helicobacter Test INFAI

13C-urea

Breath Tests Helicobacter Infections 1997-08-14           Authorised
Zontivity

vorapaxar sulfate

Myocardial Infarction 2015-01-19           Authorised
Zelboraf

vemurafenib

Melanoma 2012-02-17           Authorised
Ceprotin

human protein C

Protein C Deficiency Purpura Fulminans 2001-07-16           Authorised
Telmisartan Actavis

telmisartan

Hypertension 2010-09-30           Authorised
Volibris

ambrisentan

Hypertension, Pulmonary 2008-04-21           Authorised
Sifrol

pramipexole dihydrochloride monohydrate

Parkinson Disease Restless Legs Syndrome 1997-10-14           Authorised
Micardis

telmisartan

Hypertension 1998-12-16           Authorised
Leganto

rotigotine

Parkinson Disease Restless Legs Syndrome 2011-06-16           Authorised