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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

telotristat etiprate

Carcinoid Tumor Neuroendocrine Tumors 2017-09-18           Authorised
Bavencio

avelumab

Neuroendocrine Tumors 2017-09-18           Authorised
Rydapt

midostaurin

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

recombinant human Nerve Growth factor (rhNGF)

Keratitis 2017-07-06           Authorised
Besponsa

inotuzumab ozogamicin

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

cerliponase alfa

Neuronal Ceroid-Lipofuscinoses 2017-05-30           Authorised
Spinraza

nusinersen sodium

Muscular Atrophy, Spinal 2017-05-30           Authorised
Dinutuximab beta EUSA (previously Dinutuximab beta Apeiron)

dinutuximab beta

Neuroblastoma 2017-05-08           Authorised
Natpar

parathyroid hormone

Hypoparathyroidism 2017-04-24           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
Cystadrops

mercaptamine hydrochloride

Cystinosis 2017-01-19           Authorised
Ocaliva

obeticholic acid

Liver Cirrhosis, Biliary 2016-12-12           Authorised
SomaKit TOC

edotreotide

Neuroendocrine Tumors Radionuclide Imaging 2016-12-08           Authorised
Venclyxto

venetoclax

Leukemia, Lymphocytic, Chronic, B-Cell 2016-12-05           Authorised
Ninlaro

ixazomib citrate

Multiple Myeloma 2016-11-21           Authorised
Lartruvo

olaratumab

Sarcoma 2016-11-09           Authorised
Onivyde

irinotecan hydrochloride trihydrate

Pancreatic Neoplasms 2016-10-14           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
Dropcys

mercaptamine

Corneal Diseases Cystinosis 2016-06-24           Refused
Galafold

migalastat hydrochloride

Fabry Disease 2016-05-26           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
Darzalex

daratumumab

Multiple Myeloma 2016-05-20           Authorised
Alprolix

eftrenonacog alfa

Hemophilia B 2016-05-12           Authorised
Idelvion

albutrepenonacog alfa

Hemophilia B 2016-05-11           Authorised