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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

efavirenz / emtricitabine / tenofovir disoproxil fumarate

HIV Infections 2007-12-13           Authorised
Ritonavir Mylan

ritonavir

HIV Infections 2017-11-10           Authorised
Enyglid

repaglinide

Diabetes Mellitus, Type 2 2009-10-14           Authorised
Zavesca

miglustat

Gaucher Disease Niemann-Pick Diseases 2002-11-20           Authorised
Fuzeon

enfuvirtide

HIV Infections 2003-05-27           Authorised
Luveris

lutropin alfa

Infertility, Female Ovulation Induction 2000-11-29           Authorised
Clopidogrel HCS

clopidogrel hydrochloride

Acute Coronary Syndrome Myocardial Infarction Peripheral Vascular Diseases Stroke 2010-10-28           Authorised
Exforge

amlodipine (as besylate) / valsartan

Hypertension 2007-01-17           Authorised
Rivastigmine Hexal

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 2009-12-11           Authorised
Clopidogrel Apotex (previously Clopidogrel Mylan Pharma)

clopidogrel besilate

Myocardial Infarction Peripheral Vascular Diseases Stroke 2009-10-16           Authorised
Helicobacter Test INFAI

13C-urea

Breath Tests Helicobacter Infections 1997-08-14           Authorised
Sildenafil ratiopharm

sildenafil

Erectile Dysfunction 2009-12-23           Authorised
Zoely

nomegestrol acetate / estradiol

Contraception 2011-07-27           Authorised
Rasagiline Mylan

rasagiline tartrate

Parkinson Disease 2016-04-04           Authorised
Nevirapine Teva

nevirapine

HIV Infections 2009-11-30           Authorised
Dukoral

recombinant cholera toxin B subunit / vibrio cholerae 01

Cholera Immunization 2004-04-28           Authorised
Rivastigmine Sandoz

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 2009-12-11           Authorised
HyQvia

human normal immunoglobulin

Immunologic Deficiency Syndromes 2013-05-16           Authorised
Dificlir

fidaxomicin

Clostridium Infections 2011-12-05           Authorised
Cymbalta

duloxetine

Anxiety Disorders Depressive Disorder, Major Diabetic Neuropathies 2004-12-17           Authorised
Levodopa/Carbidopa/Entacapone Orion

levodopa / carbidopa / entacapone

Parkinson Disease 2011-08-24           Authorised
Memantine Mylan

memantine hydrochloride

Alzheimer Disease 2013-04-22           Authorised
Emend

aprepitant

Cancer Postoperative Nausea and Vomiting Vomiting 2003-11-11           Authorised
Movymia

teriparatide

Osteoporosis 2017-01-11           Authorised
Yentreve

duloxetine hydrochloride

Urinary Incontinence, Stress 2004-08-11           Authorised