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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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
Xaluprine (previously Mercaptopurine Nova Laboratories)

6-mercaptopurine monohydrate

Leukemia, Lymphoid 2012-03-09           Authorised
Scenesse

afamelanotide

Protoporphyria, Erythropoietic 2014-12-22           Authorised
Idelvion

albutrepenonacog alfa

Hemophilia B 2016-05-11           Authorised
Glybera

alipogene tiparvovec

Hyperlipoproteinemia Type I 2012-10-25           Withdrawn
Zalmoxis

Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)

Graft vs Host Disease Hematopoietic Stem Cell Transplantation 2016-08-18           Authorised
Volibris

ambrisentan

Hypertension, Pulmonary 2008-04-21           Authorised
Firdapse (previously Zenas)

amifampridine

Lambert-Eaton Myasthenic Syndrome 2009-12-23           Authorised
Strensiq

asfotase alfa

Hypophosphatasia 2015-08-28           Authorised
Translarna

ataluren

Muscular Dystrophy, Duchenne 2014-07-31           Authorised
Strimvelis

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells

Severe Combined Immunodeficiency 2016-05-26           Authorised
Bavencio

avelumab

Neuroendocrine Tumors 2017-09-18           Authorised
Vidaza

azacitidine

Myelodysplastic Syndromes 2008-12-17           Authorised
Cayston

aztreonam lysine

Cystic Fibrosis Respiratory Tract Infections 2009-09-21           Authorised
Sirturo

bedaquiline fumarate

Tuberculosis, Multidrug-Resistant 2014-03-05           Authorised
Blincyto

blinatumomab

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

bosutinib (as monohydrate)

  2013-03-27           Authorised
Adcetris

brentuximab vedotin

Hodgkin Disease Lymphoma, Non-Hodgkin 2012-10-25           Authorised
Cometriq

cabozantinib

Thyroid Neoplasms 2014-03-21           Authorised
Peyona (previously Nymusa)

caffeine citrate

Apnea 2009-07-02           Authorised
Kyprolis

carfilzomib

Multiple Myeloma 2015-11-19           Authorised
Carbaglu

carglumic acid

Amino Acid Metabolism, Inborn Errors Propionic Acidemia 2003-01-24           Authorised
Onsenal

celecoxib

Adenomatous Polyposis Coli 2003-10-17           Withdrawn
Brineura

cerliponase alfa

Neuronal Ceroid-Lipofuscinoses 2017-05-30           Authorised
Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

chenodeoxycholic acid

Metabolism, Inborn Errors Xanthomatosis, Cerebrotendinous 2017-04-10           Authorised
Ledaga

chlormethine

Mycosis Fungoides 2017-03-03           Authorised