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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

miglustat

Gaucher Disease 2017-11-10           Authorised
Cyltezo

adalimumab

Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Hidradenitis Suppurativa Psoriasis Spondylitis, Ankylosing Uveitis 2017-11-10           Authorised
Ritonavir Mylan

ritonavir

HIV Infections 2017-11-10           Authorised
Dupixent

dupilumab

Dermatitis, Atopic 2017-09-27           Authorised
Symtuza

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

HIV Infections 2017-09-21           Authorised
Tecentriq

atezolizumab

Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell 2017-09-21           Authorised
Entecavir Mylan

entecavir monohydrate

Hepatitis B 2017-09-18           Authorised
Xermelo

telotristat etiprate

Carcinoid Tumor Neuroendocrine Tumors 2017-09-18           Authorised
Rydapt

midostaurin

Leukemia, Myeloid, Acute Mastocytosis 2017-09-18           Authorised
Lacosamide Accord

lacosamide

Epilepsy 2017-09-18           Authorised
Bavencio

avelumab

Neuroendocrine Tumors 2017-09-18           Authorised
Cuprior

trientine tetrahydrochloride

Hepatolenticular Degeneration 2017-09-05           Authorised
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

efavirenz / emtricitabine / tenofovir disoproxil maleate

HIV Infections 2017-09-05           Authorised
Nitisinone MDK (previously Nitisinone MendeliKABS)

nitisinone

Tyrosinemias 2017-08-24           Authorised
Imraldi

adalimumab

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

tivozanib

Carcinoma, Renal Cell 2017-08-24           Authorised
Mavenclad

cladribine

Multiple Sclerosis 2017-08-22           Authorised
Kisqali

ribociclib succinate

Breast Neoplasms 2017-08-22           Authorised
Vosevi

sofosbuvir / velpatasvir / voxilaprevi

Hepatitis C, Chronic 2017-07-26           Authorised
Maviret glecaprevir / pibrentasvir Hepatitis C, Chronic 2017-07-26           Authorised
Insulin lispro Sanofi

insulin lispro

Diabetes Mellitus 2017-07-19           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
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

efavirenz / emtricitabine / tenofovir disoproxil, phosphate

HIV Infections 2017-07-17           Authorised
Kyntheum

brodalumab

Psoriasis 2017-07-17           Authorised