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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

insulin human

Diabetes Mellitus 2002-10-07           Authorised
Lantus

insulin glargine

Diabetes Mellitus 2000-06-09           Authorised
Modigraf

tacrolimus

Graft Rejection 2009-05-15           Authorised
DuoPlavin

clopidogrel / acetylsalicylic acid

Acute Coronary Syndrome Myocardial Infarction 2010-03-15           Authorised
DepoCyte

cytarabine

Meningeal Neoplasms 2001-07-11           Authorised
Prepandrix

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

Disease Outbreaks Immunization Influenza, Human 2008-05-14           Authorised
Exelon

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 1998-05-12           Authorised
Rapiscan

regadenoson

Myocardial Perfusion Imaging 2010-09-06           Authorised
Humalog

insulin lispro

Diabetes Mellitus 1996-04-30           Authorised
Voncento

human coagulation factor VIII / human von willebrand factor

Hemophilia A von Willebrand Diseases 2013-08-12           Authorised
Lemtrada

alemtuzumab

Multiple Sclerosis 2013-09-12           Authorised
Vipidia

alogliptin

Diabetes Mellitus, Type 2 2013-09-19           Authorised
Accofil

filgrastim

Neutropenia 2014-09-18           Authorised
Orbactiv

oritavancin diphosphate

Skin Diseases, Bacterial Soft Tissue Infections 2015-03-19           Authorised
Fendrix

hepatitis B surface antigen

Hepatitis B Immunization 2005-02-02           Authorised
Mycamine

micafungin

Candidiasis 2008-04-25           Authorised
Oncaspar

pegaspargase

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2016-01-14           Authorised
Betaferon

interferon beta-1b

Multiple Sclerosis 1995-11-30           Authorised
NeoRecormon

epoetin beta

Anemia Blood Transfusion, Autologous Cancer Kidney Failure, Chronic 1997-07-16           Authorised
Neoclarityn

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Urticaria 2001-01-15           Authorised
Kanuma

sebelipase alfa

Lipid Metabolism, Inborn Errors 2015-08-28           Authorised
Desloratadine Actavis

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Urticaria 2012-01-13           Authorised
Kovaltry

octocog alfa

Hemophilia A 2016-02-18           Authorised
CellCept

mycophenolate mofetil

Graft Rejection 1996-02-14           Authorised
Metalyse

tenecteplase

Myocardial Infarction 2001-02-23           Authorised