European public assessment reports

  • Email
  • Help

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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

Document status

Include:

Browse by letter

Browse by letter for medicines that have a European Public Assessment Report:

Or for other types of content pick from the navigation on the left.

Search by keyword

Search for keyword:

Search by therapeutic area

Browse the database based on therapeutic area:

/

Browse by type

Browse by type:

Download results to spreadsheet
EPAR Search results
Name Active substance Therapeutic area Date of authorisation / refusal Additional monitoring Orphan     Has current safety alert Status
Tasermity

sevelamer hydrochloride

Hyperphosphatemia Renal Dialysis 2015-02-26           Authorised
Pedea

ibuprofen

Ductus Arteriosus, Patent 2004-07-29           Authorised
Forsteo

teriparatide

Osteoporosis Osteoporosis, Postmenopausal 2003-06-10           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
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
Clopidogrel HCS

clopidogrel hydrochloride

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

fesoterodine fumarate

Urinary Bladder, Overactive 2007-04-20           Authorised
Hemangiol

propranolol hydrochloride

Hemangioma 2014-04-23           Authorised
Mirvaso

brimonidine tartrate

Skin Diseases 2014-02-21           Authorised
Janumet

sitagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2008-07-16           Authorised
Irbesartan Zentiva (previously Irbesartan Winthrop)

irbesartan

Hypertension 2007-01-19           Authorised
Insulin Human Winthrop

insulin human

Diabetes Mellitus 2007-01-17           Authorised
Vantobra

tobramycin

Cystic Fibrosis Respiratory Tract Infections 2015-03-18           Authorised
Byetta

exenatide

Diabetes Mellitus, Type 2 2006-11-20           Authorised
Bonviva

ibandronic acid

Osteoporosis, Postmenopausal 2004-02-23           Authorised
Clopidogrel Acino

clopidogrel

Acute Coronary Syndrome Myocardial Infarction Peripheral Vascular Diseases Stroke 2009-07-28           Authorised
Actos

pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2000-10-13           Authorised
Defitelio

defibrotide

Hepatic Veno-Occlusive Disease 2013-10-18           Authorised
Macugen

pegaptanib

Wet Macular Degeneration 2006-01-31           Authorised
Vargatef

nintedanib

Carcinoma, Non-Small-Cell Lung 2014-11-21           Authorised
Olanzapine Glenmark Europe

olanzapine

Bipolar Disorder Schizophrenia 2009-12-03           Authorised