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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

metreleptin

Lipodystrophy, Familial Partial 2018-07-30           Authorised
Nityr

nitisinone

Tyrosinemias 2018-07-26           Authorised
Aimovig

erenumab

Migraine Disorders 2018-07-26           Authorised
Hyrimoz

adalimumab

Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Hidradenitis Suppurativa Skin Diseases, Papulosquamous Spondylitis, Ankylosing Uveitis 2018-07-26           Authorised
Trazimera

trastuzumab

Breast Neoplasms Stomach Neoplasms 2018-07-26           Authorised
Hefiya

adalimumab

Arthritis, Juvenile Rheumatoid Hidradenitis Suppurativa Psoriasis Spondylitis, Ankylosing Uveitis 2018-07-26           Authorised
Halimatoz

adalimumab

Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Hidradenitis Suppurativa Psoriasis Spondylitis, Ankylosing Uveitis 2018-07-26           Authorised
Verkazia

ciclosporin

Conjunctivitis Keratitis 2018-07-06           Authorised
Tegsedi

inotersen sodium

Amyloidosis 2018-07-06           Authorised
Dzuveo

sufentanil citrate

Pain 2018-06-25           Authorised
Biktarvy

bictegravir / emtricitabine / tenofovir alafenamide / fumarate

HIV Infections 2018-06-21           Authorised
Amglidia

glibenclamide

Diabetes Mellitus 2018-05-24           Authorised
Rubraca

rucaparib camsylate

Ovarian Neoplasms 2018-05-24           Authorised
Pemetrexed Krka

pemetrexed disodium

Carcinoma, Non-Small-Cell Lung Mesothelioma 2018-05-22           Authorised
Zessly

infliximab

Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Psoriasis Spondylitis, Ankylosing 2018-05-18           Authorised
Prasugrel Mylan

prasugrel besilate

Acute Coronary Syndrome Angina, Unstable Myocardial Infarction 2018-05-16           Authorised
Juluca

 dolutegravir sodium,rilpivirine hydrochloride

HIV Infections 2018-05-16           Authorised
Kanjinti

trastuzumab

Breast Neoplasms Stomach Neoplasms 2018-05-16           Authorised
Trydonis

beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium

Pulmonary Disease, Chronic Obstructive 2018-04-26           Authorised
Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)

beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium

Pulmonary Disease, Chronic Obstructive 2018-04-23           Authorised
Mylotarg

gemtuzumab ozogamicin

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

peramivir

Influenza, Human 2018-04-13           Authorised
Lamzede

velmanase alfa

alpha-Mannosidosis 2018-03-23           Authorised
Semglee

insulin glargine

Diabetes Mellitus 2018-03-23           Authorised
Steglujan

ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate

Diabetes Mellitus, Type 2 2018-03-23           Authorised