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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

afatinib

Carcinoma, Non-Small-Cell Lung 2013-09-25           Authorised
Tecfidera

dimethyl fumarate

Multiple Sclerosis 2014-01-30           Authorised
Bexsero

recombinant Neisseria meningitidis group-B NHBA fusion protein / recombinant Neisseria meningitidis group-B NadA protein / recombinant Neisseria meningitidis group B fHbp fusion protein / outer membrane vesicles from Neisseria meningitidis group-B strain NZ98 / 254 measured as amount of total protein containing the PorA P1.4

Meningitis, Meningococcal 2013-01-14           Authorised
Trimbow

beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium bromide

Pulmonary Disease, Chronic Obstructive 2017-07-17           Authorised
Ravicti

 glycerol phenylbutyrate

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

5-aminolevulinic acid hydrochloride

Glioma 2007-09-07           Authorised
Ameluz

5-aminolevulinic acid hydrochloride

Keratosis, Actinic 2011-12-14           Authorised
Xaluprine (previously Mercaptopurine Nova Laboratories)

6-mercaptopurine monohydrate

Leukemia, Lymphoid 2012-03-09           Authorised
Holoclar

ex vivo expanded autologous human corneal epithelial cells containing stem cells

Corneal Diseases Stem Cell Transplantation 2015-02-17           Authorised
Nimenrix

Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid

Meningitis, Meningococcal 2012-04-20           Authorised
Trumenba

Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B

Meningitis, Meningococcal 2017-05-24           Authorised
Helicobacter Test INFAI

13C-urea

Breath Tests Helicobacter Infections 1997-08-14           Authorised
Pylobactell

13C-urea

Breath Tests Helicobacter Infections 1998-05-07           Authorised
Prepandrix

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

Disease Outbreaks Immunization Influenza, Human 2008-05-14           Authorised
Trizivir

abacavir (as sulfate) / lamivudine / zidovudine

HIV Infections 2000-12-28           Authorised
Kivexa

abacavir / lamivudine

HIV Infections 2004-12-17           Authorised
Triumeq

abacavir sulfate / dolutegravir sodium / lamivudine

HIV Infections 2014-09-01           Authorised
Ziagen

abacavir

HIV Infections 1999-07-08           Authorised
Orencia

abatacept

Arthritis, Juvenile Rheumatoid Arthritis, Rheumatoid 2007-05-21           Authorised
Zytiga

abiraterone acetate

Prostatic Neoplasms 2011-09-05           Authorised
Brimica Genuair

aclidinium / formoterol fumarate dihydrate

Pulmonary Disease, Chronic Obstructive 2014-11-19           Authorised
Duaklir Genuair

aclidinium bromide / formoterol fumarate dihydrate

Pulmonary Disease, Chronic Obstructive 2014-11-19           Authorised
Eklira Genuair

aclidinium bromide, micronised

Pulmonary Disease, Chronic Obstructive 2012-07-20           Authorised
Bretaris Genuair

aclidinium bromide, micronised

Pulmonary Disease, Chronic Obstructive 2012-07-20           Authorised
Imraldi

adalimumab

Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Hidradenitis Suppurativa Psoriasis Spondylitis, Ankylosing Uveitis 2017-08-24           Authorised