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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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
Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)

clopidogrel / acetylsalicylic acid

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

daptomycin

Bacteremia Endocarditis, Bacterial Gram-Positive Bacterial Infections Soft Tissue Infections 2006-01-19           Authorised
Extavia

interferon beta-1b

Multiple Sclerosis 2008-05-20           Authorised
Palonosetron Accord

palonosetron

Cancer Nausea Vomiting 2016-05-26           Authorised
Victoza

liraglutide

Diabetes Mellitus, Type 2 2009-06-30           Authorised
Rivastigmine Actavis

rivastigmine hydrogen tartrate

Alzheimer Disease Dementia Parkinson Disease 2011-06-16           Authorised
Foscan

temoporfin

Carcinoma, Squamous Cell Head and Neck Neoplasms 2001-10-24           Authorised
Imnovid (previously Pomalidomide Celgene)

pomalidomide

Multiple Myeloma 2013-08-05           Authorised
Senshio

ospemifene

Postmenopause 2015-01-15           Authorised
Onivyde

irinotecan hydrochloride trihydrate

Pancreatic Neoplasms 2016-10-14           Authorised
Simbrinza

brinzolamide / brimonidine tartrate

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

clopidogrel hydrochloride

Myocardial Infarction Peripheral Vascular Diseases Stroke 2009-09-23           Authorised
Cometriq

cabozantinib

Thyroid Neoplasms 2014-03-21           Authorised
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)

aripiprazole

Bipolar Disorder Schizophrenia 2015-06-30           Authorised
Erivedge

vismodegib

Carcinoma, Basal Cell 2013-07-12           Authorised
Odomzo

sonidegib diphosphate

Carcinoma, Basal Cell 2015-08-14           Authorised
Evra

norelgestromin / ethinyl estradiol

Contraception 2002-08-22           Authorised
Epivir

lamivudine

HIV Infections 1996-08-08           Authorised
Myocet

doxorubicin hydrochloride

Breast Neoplasms 2000-07-13           Authorised
Vimizim

recombinant human n-acetylgalactosamine-6-sulfatase (rhgalns)

Mucopolysaccharidosis IV 2014-04-28           Authorised
Raxone

idebenone

Optic Atrophy, Hereditary, Leber 2015-09-08           Authorised
Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)

levodopa / carbidopa / entacapone

Nervous System Diseases Neurodegenerative Diseases Parkinson Disease 2013-11-11           Authorised
Zutectra

human hepatitis-B immunoglobulin

Hepatitis B Immunization, Passive Liver Transplantation 2009-11-30           Authorised
NexoBrid

concentrate of proteolytic enzymes enriched in bromelain

Debridement 2012-12-18           Authorised
Pritor

telmisartan

Hypertension 1998-12-11           Authorised