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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

decitabine

Leukemia, Myeloid 2012-09-20           Authorised
Granupas (previously Para-aminosalicylic acid Lucane)

para-aminosalicylic acid

Tuberculosis 2014-04-07           Authorised
Dropcys

mercaptamine

Corneal Diseases Cystinosis 2016-06-24           Refused
Mycograb

recombinant human monoclonal antibody to hsp

Candidiasis 2007-05-22           Refused
Xaluprine (previously Mercaptopurine Nova Laboratories)

6-mercaptopurine monohydrate

Leukemia, Lymphoid 2012-03-09           Authorised
Tasigna

nilotinib

Leukemia, Myelogenous, Chronic, BCR-ABL Positive 2007-11-19           Authorised
Arzerra

ofatumumab

Leukemia, Lymphocytic, Chronic, B-Cell 2010-04-19           Authorised
Votubia

everolimus

Tuberous Sclerosis 2011-09-02           Authorised
Tobi Podhaler

tobramycin

Cystic Fibrosis Respiratory Tract Infections 2011-07-20           Authorised
Carbaglu

carglumic acid

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

mercaptamine hydrochloride

Cystinosis 2017-01-19           Authorised
Onsenal

celecoxib

Adenomatous Polyposis Coli 2003-10-17           Withdrawn
Torisel

temsirolimus

Carcinoma, Renal Cell Lymphoma, Mantle-Cell 2007-11-19           Authorised
Elelyso

taliglucerase alfa

Gaucher Disease 2012-10-25           Refused
Yondelis

trabectedin

Ovarian Neoplasms Sarcoma 2007-09-17           Authorised
Bronchitol

mannitol

Cystic Fibrosis 2012-04-13           Authorised
Rilonacept Regeneron (previously Arcalyst)

rilonacept

Cryopyrin-associated Periodic Syndromes 2009-10-23           Withdrawn
Raxone

idebenone

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

icatibant

Angioedemas, Hereditary 2008-07-11           Authorised
Vpriv

velaglucerase alfa

Gaucher Disease 2010-08-26           Authorised
Plenadren

hydrocortisone

Adrenal Insufficiency 2011-11-03           Authorised
Mepact

mifamurtide

Osteosarcoma 2009-03-06           Authorised
Unituxin

dinutuximab

Neuroblastoma 2015-08-14           Withdrawn
Hetlioz

tasimelteon

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

gemtuzumab ozogamicin

Leukemia, Myeloid, Acute 2008-04-14           Refused