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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

ivabradine hydrochloride

Angina Pectoris Heart Failure 2017-05-22           Authorised
Axumin

fluciclovine (18F)

Prostatic Neoplasms Radionuclide Imaging 2017-05-22           Authorised
Dinutuximab beta Apeiron

dinutuximab beta

Neuroblastoma 2017-05-08           Authorised
Emtricitabine/Tenofovir disoproxil Krka d.d.

emtricitabine / tenofovir disoproxil succinate

HIV Infections 2017-04-28           Authorised
Natpar

parathyroid hormone

Hypoparathyroidism 2017-04-24           Authorised
Pemetrexed Hospira UK Limited

pemetrexed ditromethamine

Carcinoma, Non-Small-Cell Lung Mesothelioma 2017-04-24           Authorised
Roteas

edoxaban tosylate

Stroke Venous Thromboembolism 2017-04-20           Authorised
Varuby

rolapitant

Cancer Nausea Vomiting 2017-04-20           Authorised
Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

chenodeoxycholic acid

Metabolism, Inborn Errors Xanthomatosis, Cerebrotendinous 2017-04-10           Authorised
Jylamvo

methotrexate

Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Psoriasis 2017-03-29           Authorised
Xeljanz

tofacitinib citrate

Arthritis, Rheumatoid 2017-03-22           Authorised
Daptomycin Hospira

daptomycin

Skin Diseases, Bacterial Soft Tissue Infections 2017-03-22           Authorised
Yargesa

miglustat

Gaucher Disease 2017-03-22           Authorised
Tadalafil Lilly

tadalafil

Erectile Dysfunction 2017-03-22           Authorised
Solymbic

adalimumab

Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Hidradenitis Suppurativa Psoriasis Spondylitis, Ankylosing 2017-03-22           Authorised
Amgevita

adalimumab

Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Psoriasis Spondylitis, Ankylosing 2017-03-22           Authorised