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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

aclidinium bromide / formoterol fumarate dihydrate

Pulmonary Disease, Chronic Obstructive 2014-11-19           Authorised
Entresto

sacubitril / valsartan

Heart Failure 2015-11-19           Authorised
Pixuvri

pixantrone dimaleate

Lymphoma, Non-Hodgkin 2012-05-10           Authorised
Lucentis

ranibizumab

Diabetes Complications Macular Edema Myopia, Degenerative Wet Macular Degeneration 2007-01-22           Authorised
Hemangiol

propranolol hydrochloride

Hemangioma 2014-04-23           Authorised
Pedea

ibuprofen

Ductus Arteriosus, Patent 2004-07-29           Authorised
Ecalta

anidulafungin

Candidiasis 2007-09-20           Authorised
Thymanax

agomelatine

Depressive Disorder, Major 2009-02-19           Authorised
Caprelsa

vandetanib

Thyroid Neoplasms 2012-02-17           Authorised
Zessly

infliximab

Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Psoriasis Spondylitis, Ankylosing 2018-05-18           Authorised
Mircera

methoxy polyethylene glycol-epoetin beta

Anemia Kidney Failure, Chronic 2007-07-20           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
Torisel

temsirolimus

Carcinoma, Renal Cell Lymphoma, Mantle-Cell 2007-11-19           Authorised
Opatanol

olopatadine hydrochloride

Conjunctivitis, Allergic 2002-05-17           Authorised
Rapilysin

reteplase

Myocardial Infarction 1996-08-29           Authorised
Ucedane

carglumic acid

Amino Acid Metabolism, Inborn Errors Hyperammonemia 2017-06-23           Authorised
Vantavo (previously Alendronate sodium and colecalciferol, MSD)

alendronic acid / colecalciferol

Osteoporosis, Postmenopausal 2009-10-16           Authorised
Avamys

fluticasone furoate

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal 2008-01-11           Authorised
Conbriza

bazedoxifene

Osteoporosis, Postmenopausal 2009-04-17           Authorised
Pregabalin Sandoz

pregabalin

Anxiety Disorders Epilepsy Neuralgia 2015-06-19           Authorised
Glustin

pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2000-10-11           Authorised
Entacapone Orion

entacapone

Parkinson Disease 2011-08-18           Authorised
Marixino (previously Maruxa)

memantine hydrochloride

Alzheimer Disease 2013-04-29           Authorised