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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

paliperidone

Psychotic Disorders Schizophrenia 2007-06-25           Authorised
Fareston

toremifene

Breast Neoplasms 1996-02-14           Authorised
Alli (previously Orlistat GSK)

orlistat

Obesity 2007-07-23           Authorised
Targretin

bexarotene

Lymphoma, T-Cell, Cutaneous 2001-03-29           Authorised
Eklira Genuair

aclidinium bromide, micronised

Pulmonary Disease, Chronic Obstructive 2012-07-20           Authorised
Lonquex

lipegfilgrastim

Neutropenia 2013-07-25           Authorised
Zavesca

miglustat

Gaucher Disease Niemann-Pick Diseases 2002-11-20           Authorised
Rasilez HCT

aliskiren / hydrochlorothiazide

Hypertension 2009-01-16           Authorised
Ziagen

abacavir

HIV Infections 1999-07-08           Authorised
Pregabalin Accord

pregabalin

Anxiety Disorders Epilepsy 2015-08-28           Authorised
Tasermity

sevelamer hydrochloride

Hyperphosphatemia Renal Dialysis 2015-02-26           Authorised
Constella

linaclotide

Irritable Bowel Syndrome 2012-11-26           Authorised
Pedea

ibuprofen

Ductus Arteriosus, Patent 2004-07-29           Authorised
Forsteo

teriparatide

Osteoporosis Osteoporosis, Postmenopausal 2003-06-10           Authorised
Intelence

etravirine

HIV Infections 2008-08-28           Authorised
Nuwiq

simoctocog alfa

Hemophilia A 2014-07-22           Authorised
Ecalta

anidulafungin

Candidiasis 2007-09-20           Authorised
Pregabalin Sandoz

pregabalin

Anxiety Disorders Epilepsy Neuralgia 2015-06-19           Authorised
Dificlir

fidaxomicin

Clostridium Infections 2011-12-05           Authorised
Daliresp

roflumilast

Pulmonary Disease, Chronic Obstructive 2011-02-28           Authorised
Renagel

sevelamer

Hyperphosphatemia Renal Dialysis 2000-01-28           Authorised
Rilutek

riluzole

Amyotrophic Lateral Sclerosis 1996-06-10           Authorised
Toviaz

fesoterodine fumarate

Urinary Bladder, Overactive 2007-04-20           Authorised
Cotellic

cobimetinib hemifumarate

Melanoma 2015-11-20           Authorised
Hemangiol

propranolol hydrochloride

Hemangioma 2014-04-23           Authorised