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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

melatonin

Sleep Initiation and Maintenance Disorders 2007-06-29           Authorised
Respreeza

alpha1-proteinase inhibitor (human)

Genetic Diseases, Inborn Lung Diseases 2015-08-20           Authorised
ATryn

antithrombin alfa

Antithrombin III Deficiency 2006-07-28           Authorised
Invokana

canagliflozin

Diabetes Mellitus, Type 2 2013-11-15           Authorised
Kaletra

lopinavir / ritonavir

HIV Infections 2001-03-20           Authorised
Ebilfumin

oseltamivir

Influenza, Human 2014-05-22           Authorised
Repaglinide Accord

repaglinide

Diabetes Mellitus, Type 2 2011-12-22           Authorised
Lamivudine Teva

lamivudine

Hepatitis B, Chronic 2009-10-23           Authorised
Nimenrix

Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid

Meningitis, Meningococcal 2012-04-20           Authorised
Elaprase

idursulfase

Mucopolysaccharidosis II 2007-01-08           Authorised
Amlodipine / Valsartan Mylan

amlodipine besilate / valsartan

Hypertension 2016-03-22           Authorised
Ferriprox

deferiprone

Iron Overload beta-Thalassemia 1999-08-25           Authorised
Halaven

eribulin

Breast Neoplasms Liposarcoma 2011-03-17           Authorised
Iasibon

ibandronic acid

Breast Neoplasms Fractures, Bone Hypercalcemia Neoplasm Metastasis 2011-01-21           Authorised
Pemetrexed Lilly

pemetrexed

Carcinoma, Non-Small-Cell Lung Mesothelioma 2015-09-14           Authorised
Pemetrexed Sandoz

pemetrexed disodium hemipentahydrate

Carcinoma, Non-Small-Cell Lung Mesothelioma 2015-09-18           Authorised
Zoely

nomegestrol acetate / estradiol

Contraception 2011-07-27           Authorised
Temozolomide Sandoz

temozolomide

Glioblastoma Glioma 2010-03-15           Authorised
Fulvestrant Mylan

fulvestrant

Breast Neoplasms 2018-01-08           Authorised
Lyrica

pregabalin

Anxiety Disorders Epilepsy Neuralgia 2004-07-06           Authorised
Vemlidy

tenofovir alafenamide fumarate

Hepatitis B 2017-01-09           Authorised
Ovitrelle

choriogonadotropin alfa

Anovulation Infertility, Female Reproductive Techniques, Assisted 2001-02-02           Authorised
Starlix

nateglinide

Diabetes Mellitus, Type 2 2001-04-03           Authorised
Portrazza

necitumumab

Carcinoma, Non-Small-Cell Lung 2016-02-15           Authorised
Synagis

palivizumab

Respiratory Syncytial Virus Infections 1999-08-13           Authorised