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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

brimonidine tartrate

Skin Diseases 2014-02-21           Authorised
Irbesartan Zentiva (previously Irbesartan Winthrop)

irbesartan

Hypertension 2007-01-19           Authorised
Insulin Human Winthrop

insulin human

Diabetes Mellitus 2007-01-17           Authorised
Tyverb

lapatinib

Breast Neoplasms 2008-06-10           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
Vizarsin

sildenafil

Erectile Dysfunction 2009-09-21           Authorised
Olanzapine Glenmark Europe

olanzapine

Bipolar Disorder Schizophrenia 2009-12-03           Authorised
Aloxi

palonosetron hydrochloride

Cancer Vomiting 2005-03-22           Authorised
Repaglinide Krka

repaglinide

Diabetes Mellitus, Type 2 2009-11-04           Authorised
Tolucombi

telmisartan / hydrochlorothiazide

Hypertension 2013-03-13           Authorised
Comtan

entacapone

Parkinson Disease 1998-09-22           Authorised
Eviplera

emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate

HIV Infections 2011-11-28           Authorised
Inlyta

axitinib

Carcinoma, Renal Cell 2012-09-03           Authorised
Busilvex

busulfan

Hematopoietic Stem Cell Transplantation 2003-07-09           Authorised
Temozolomide Hexal

temozolomide

Glioblastoma Glioma 2010-03-15           Authorised
Samsca

tolvaptan

Inappropriate ADH Syndrome 2009-08-03           Authorised
Topotecan Teva

topotecan

Ovarian Neoplasms Small Cell Lung Carcinoma Uterine Cervical Neoplasms 2009-09-21           Authorised
Eylea

aflibercept

Diabetes Complications Macular Edema Wet Macular Degeneration 2012-11-22           Authorised
Galafold

migalastat hydrochloride

Fabry Disease 2016-05-26           Authorised