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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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
Dinutuximab beta EUSA (previously Dinutuximab beta Apeiron)

dinutuximab beta

Neuroblastoma 2017-05-08           Authorised
Lenvima

lenvatinib mesylate

Thyroid Neoplasms 2015-05-28           Authorised
Defitelio

defibrotide

Hepatic Veno-Occlusive Disease 2013-10-18           Authorised
Cerdelga

eliglustat

Gaucher Disease 2015-01-19           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
Ravicti

 glycerol phenylbutyrate

Urea Cycle Disorders, Inborn 2015-11-27           Authorised
Ocaliva

obeticholic acid

Liver Cirrhosis, Biliary 2016-12-12           Authorised
Cometriq

cabozantinib

Thyroid Neoplasms 2014-03-21           Authorised
Xermelo

telotristat etiprate

Carcinoid Tumor Neuroendocrine Tumors 2017-09-18           Authorised
Darzalex

daratumumab

Multiple Myeloma 2016-05-20           Authorised
Sirturo

bedaquiline fumarate

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

ibrutinib

Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell 2014-10-21           Authorised
Sylvant

siltuximab

Giant Lymph Node Hyperplasia 2014-05-22           Authorised
Ketoconazole HRA

ketoconazole

Cushing Syndrome 2014-11-19           Authorised
Orphacol

cholic acid

Digestive System Diseases Metabolism, Inborn Errors 2013-09-12           Authorised
Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

chenodeoxycholic acid

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

histamine dihydrochloride

Leukemia, Myeloid, Acute 2008-10-07           Authorised
NexoBrid

concentrate of proteolytic enzymes enriched in bromelain

Debridement 2012-12-18           Authorised
Bavencio

avelumab

Neuroendocrine Tumors 2017-09-18           Authorised
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
Signifor

pasireotide

Acromegaly Pituitary ACTH Hypersecretion 2012-04-24           Authorised
Farydak

panobinostat lactate anhydrous

Multiple Myeloma 2015-08-28           Authorised
Rydapt

midostaurin

Leukemia, Myeloid, Acute Mastocytosis 2017-09-18           Authorised
Deltyba

delamanid

Tuberculosis, Multidrug-Resistant 2014-04-28           Authorised
Translarna

ataluren

Muscular Dystrophy, Duchenne 2014-07-31           Authorised