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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

migalastat hydrochloride

Fabry Disease 2016-05-26           Authorised
Temozolomide Sun

temozolomide

Glioblastoma Glioma 2011-07-13           Authorised
Pramipexole Accord

pramipexole dihydrochloride monohydrate

Parkinson Disease Restless Legs Syndrome 2011-09-30           Authorised
Atosiban SUN

atosiban acetate

Premature Birth 2013-07-31           Authorised
Edarbi

azilsartan medoxomil

Hypertension 2011-12-07           Authorised
Faslodex

fulvestrant

Breast Neoplasms 2004-03-10           Authorised
Sycrest

asenapine maleate 

Bipolar Disorder 2010-09-01           Authorised
Conbriza

bazedoxifene

Osteoporosis, Postmenopausal 2009-04-17           Authorised
Ristempa

pegfilgrastim

Neutropenia 2015-04-13           Authorised
Glustin

pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2000-10-11           Authorised
Nplate

romiplostim

Purpura, Thrombocytopenic, Idiopathic 2009-02-04           Authorised
Zaltrap

aflibercept

Colorectal Neoplasms 2013-02-01           Authorised
Spectrila

asparaginase

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2016-01-14           Authorised
Entacapone Orion

entacapone

Parkinson Disease 2011-08-18           Authorised
Exviera

dasabuvir sodium

Hepatitis C, Chronic 2015-01-15           Authorised
Zyllt

clopidogrel hydrogen sulphate

Acute Coronary Syndrome Myocardial Infarction Peripheral Vascular Diseases Stroke 2009-09-28           Authorised
Nordimet

methotrexate

Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Psoriasis 2016-08-18           Authorised