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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2008-09-15           Withdrawn
Epoetin Alfa Hexal

epoetin alfa

Anemia Cancer Kidney Failure, Chronic 2007-08-28           Authorised
Solumarv

insulin human

Diabetes Mellitus 2015-11-19           Refused
Filgrastim Hexal

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2009-02-06           Authorised
Ritemvia

rituximab

Lymphoma, Non-Hodgkin Microscopic Polyangiitis Wegener Granulomatosis 2017-07-13           Authorised
Ovaleap

follitropin alfa

Anovulation 2013-09-27           Authorised
Imraldi

adalimumab

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

somatropin

Dwarfism, Pituitary Prader-Willi Syndrome Turner Syndrome 2006-04-12           Authorised
Biograstim

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2008-09-15           Withdrawn
Blitzima

rituximab

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

epoetin zeta

Anemia Blood Transfusion, Autologous Cancer Kidney Failure, Chronic 2007-12-18           Authorised
Lusduna

insulin glargine

Diabetes Mellitus 2017-01-04           Authorised
Ratiograstim

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2008-09-15           Authorised
Zarzio

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2009-02-06           Authorised
Amgevita

adalimumab

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

teriparatide

Osteoporosis 2017-01-11           Authorised
Thorinane

enoxaparin sodium

Venous Thromboembolism 2016-09-15           Authorised
Alpheon

recombinant human interferon alfa-2a

Hepatitis C, Chronic 2006-09-05           Refused
Solymbic

adalimumab

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

insulin lispro

Diabetes Mellitus 2017-07-19           Authorised
Abseamed

epoetin alfa

Anemia Cancer Kidney Failure, Chronic 2007-08-28           Authorised
Inflectra

infliximab

Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Psoriasis Spondylitis, Ankylosing 2013-09-10           Authorised
Remsima

infliximab

Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Psoriasis Spondylitis, Ankylosing 2013-09-10           Authorised
Nivestim

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2010-06-08           Authorised
Abasaglar (previously Abasria)

insulin glargine

Diabetes Mellitus 2014-09-09           Authorised