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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

asparaginase

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2016-01-14           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
Temodal

temozolomide

Glioblastoma Glioma 1999-01-26           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
Emend

aprepitant

Cancer Postoperative Nausea and Vomiting Vomiting 2003-11-11           Authorised
Entacapone Orion

entacapone

Parkinson Disease 2011-08-18           Authorised
Insuman

insulin human

Diabetes Mellitus 1997-02-21           Authorised
Exviera

dasabuvir sodium

Hepatitis C, Chronic 2015-01-15           Authorised
Clopidogrel Mylan

clopidogrel hydrochloride

Myocardial Infarction Peripheral Vascular Diseases Stroke 2009-09-21           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
Cresemba

isavuconazole

Aspergillosis 2015-10-15           Authorised
Idelvion

albutrepenonacog alfa

Hemophilia B 2016-05-11           Authorised
Ionsys

fentanyl hydrochloride

Pain, Postoperative 2015-11-19           Authorised
Blincyto

blinatumomab

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2015-11-23           Authorised
Neparvis

sacubitril / valsartan

Heart Failure 2016-05-26           Authorised
Glyxambi

empagliflozin / linagliptin

Diabetes Mellitus, Type 2 2016-11-11           Authorised