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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

yttrium [90Y] chloride

Radionuclide Imaging 2003-03-24           Authorised
Lantus

insulin glargine

Diabetes Mellitus 2000-06-09           Authorised
Visudyne

verteporfin

Macular Degeneration Myopia, Degenerative 2000-07-27           Authorised
SomaKit TOC

edotreotide

Neuroendocrine Tumors Radionuclide Imaging 2016-12-08           Authorised
Advagraf

tacrolimus

Graft Rejection 2007-04-23           Authorised
Replagal

agalsidase alfa

Fabry Disease 2001-08-03           Authorised
Liprolog

insulin lispro

Diabetes Mellitus 2001-08-01           Authorised
Vipidia

alogliptin

Diabetes Mellitus, Type 2 2013-09-19           Authorised
Olumiant

baricitinib

Arthritis, Rheumatoid 2017-02-13           Authorised
Orbactiv

oritavancin diphosphate

Skin Diseases, Bacterial Soft Tissue Infections 2015-03-19           Authorised
Imatinib Teva

imatinib

Dermatofibrosarcoma Hypereosinophilic Syndrome Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic-Myeloproliferative Diseases Precursor Cell Lymphoblastic Leukemia-Lymphoma 2013-01-08           Authorised
Janumet

sitagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2008-07-16           Authorised
Tolucombi

telmisartan / hydrochlorothiazide

Hypertension 2013-03-13           Authorised
Suboxone

buprenorphine / naloxone

Opioid-Related Disorders 2006-09-26           Authorised
Eptifibatide Accord

eptifibatide

Myocardial Infarction 2016-01-11           Authorised
Vpriv

velaglucerase alfa

Gaucher Disease 2010-08-26           Authorised
Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Hypertension 2009-10-16           Authorised
Altargo

retapamulin

Impetigo Staphylococcal Skin Infections 2007-05-24           Authorised
Ibandronic Acid Sandoz

ibandronic acid

Breast Neoplasms Fractures, Bone Neoplasm Metastasis 2011-07-26           Authorised
Exforge

amlodipine (as besylate) / valsartan

Hypertension 2007-01-17           Authorised
Levitra

vardenafil

Erectile Dysfunction 2003-03-06           Authorised
Zykadia

ceritinib

Carcinoma, Non-Small-Cell Lung 2015-05-06           Authorised
Champix

varenicline

Tobacco Use Cessation 2006-09-26           Authorised
Prandin

repaglinide

Diabetes Mellitus, Type 2 2001-01-29           Authorised
Scintimun

besilesomab

Osteomyelitis Radionuclide Imaging 2010-01-11           Authorised