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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

adalimumab

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

cladribine

Multiple Sclerosis 2017-08-22           Authorised
Kisqali

ribociclib succinate

Breast Neoplasms 2017-08-22           Authorised
Maviret glecaprevir / pibrentasvir Hepatitis C, Chronic 2017-07-26           Authorised
Veltassa

patiromer sorbitex calcium

Hyperkalemia 2017-07-19           Authorised
Trimbow

beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium bromide

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

brodalumab

Psoriasis 2017-07-17           Authorised
Reagila

cariprazine hydrochloride

Schizophrenia 2017-07-13           Authorised
Ritemvia

rituximab

Lymphoma, Non-Hodgkin Microscopic Polyangiitis Wegener Granulomatosis 2017-07-13           Authorised
Rituzena (previously Tuxella)

rituximab

Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin Microscopic Polyangiitis Wegener Granulomatosis 2017-07-13           Authorised
Blitzima

rituximab

Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin 2017-07-13           Authorised
Spherox

spheroids of human autologous matrix-associated chondrocytes

Cartilage Diseases 2017-07-10           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
Ucedane

carglumic acid

Amino Acid Metabolism, Inborn Errors Hyperammonemia 2017-06-23           Authorised
Skilarence

dimethyl fumarate

Psoriasis 2017-06-23           Authorised
Erelzi

etanercept

Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Psoriasis Spondylitis, Ankylosing 2017-06-23           Authorised
Kevzara

sarilumab

Arthritis, Rheumatoid 2017-06-23           Authorised
Riximyo

rituximab

Arthritis, Rheumatoid Lymphoma, Non-Hodgkin Microscopic Polyangiitis Wegener Granulomatosis 2017-06-15           Authorised
Rixathon

rituximab

Arthritis, Rheumatoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin Microscopic Polyangiitis Wegener Granulomatosis 2017-06-15           Authorised
Refixia

nonacog beta pegol

Hemophilia B 2017-06-02           Authorised
Elmiron

pentosan polysulfate sodium

Cystitis, Interstitial 2017-06-02           Authorised
Brineura

cerliponase alfa

Neuronal Ceroid-Lipofuscinoses 2017-05-30           Authorised
Spinraza

nusinersen sodium

Muscular Atrophy, Spinal 2017-05-30           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