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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

concentrate of proteolytic enzymes enriched in bromelain

Debridement 2012-12-18           Authorised
Bavencio

avelumab

Neuroendocrine Tumors 2017-09-18           Authorised
Prevymis

letermovir

Cytomegalovirus Infections 2018-01-08           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
Farydak

panobinostat lactate anhydrous

Multiple Myeloma 2015-08-28           Authorised
Rydapt

midostaurin

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

histamine dihydrochloride

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

delamanid

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

ataluren

Muscular Dystrophy, Duchenne 2014-07-31           Authorised
Mylotarg

gemtuzumab ozogamicin

Leukemia, Myeloid, Acute 2018-04-19           Authorised
Besponsa

inotuzumab ozogamicin

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2017-06-29           Authorised
Vyndaqel

tafamidis

Amyloidosis 2011-11-16           Authorised
Kolbam

cholic acid

Metabolism, Inborn Errors 2015-11-20           Authorised
Gazyvaro

obinutuzumab

Leukemia, Lymphocytic, Chronic, B-Cell 2014-07-23           Authorised
Raxone

idebenone

Optic Atrophy, Hereditary, Leber 2015-09-08           Authorised
Natpar

parathyroid hormone

Hypoparathyroidism 2017-04-24           Authorised
Revestive

teduglutide

Malabsorption Syndromes 2012-08-30           Authorised
Alprolix

eftrenonacog alfa

Hemophilia B 2016-05-12           Authorised
Adcetris

brentuximab vedotin

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

darvadstrocel

Rectal Fistula 2018-03-23           Authorised
Ninlaro

ixazomib citrate

Multiple Myeloma 2016-11-21           Authorised
Zejula

niraparib tosylate monohydrate

Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms 2017-11-16           Authorised
Hetlioz

tasimelteon

Sleep Disorders, Circadian Rhythm 2015-07-03           Authorised
Kalydeco

ivacaftor

Cystic Fibrosis 2012-07-23           Authorised
Glybera

alipogene tiparvovec

Hyperlipoproteinemia Type I 2012-10-25           Withdrawn