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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

paclitaxel

Breast Neoplasms 2008-01-11           Authorised
Afinitor

everolimus

Breast Neoplasms 2009-08-03           Authorised
Avastin

bevacizumab

Breast Neoplasms 2005-01-12           Authorised
Bondronat

ibandronic acid

Breast Neoplasms 1996-06-25           Authorised
Caelyx

doxorubicin hydrochloride

Breast Neoplasms 1996-06-21           Authorised
Capecitabine Accord

capecitabine

Breast Neoplasms 2012-04-20           Authorised
Capecitabine Teva

capecitabine

Breast Neoplasms 2012-04-20           Authorised
Docetaxel Accord

docetaxel

Breast Neoplasms 2012-05-22           Authorised
Docetaxel Kabi

docetaxel

Breast Neoplasms 2012-05-22           Authorised
Docetaxel Teva

docetaxel

Breast Neoplasms 2010-01-26           Authorised
Docetaxel Winthrop

docetaxel

Breast Neoplasms 2007-04-20           Authorised
Ecansya (previously Capecitabine Krka)

capecitabine

Breast Neoplasms 2012-04-20           Authorised
Fareston

toremifene

Breast Neoplasms 1996-02-14           Authorised
Faslodex

fulvestrant

Breast Neoplasms 2004-03-10           Authorised
Halaven

eribulin

Breast Neoplasms 2011-03-17           Authorised
Herceptin

trastuzumab

Breast Neoplasms 2000-08-28           Authorised
Iasibon

ibandronic acid

Breast Neoplasms 2011-01-21           Authorised
Ibandronic Acid Sandoz

ibandronic acid

Breast Neoplasms 2011-07-26           Authorised
Ibandronic Acid Teva

ibandronic acid

Breast Neoplasms 2010-09-17           Authorised
Ibrance

palbociclib

Breast Neoplasms 2016-11-09           Authorised
Kadcyla

trastuzumab emtansine

Breast Neoplasms 2013-11-15           Authorised
Kisqali

ribociclib succinate

Breast Neoplasms 2017-08-22           Authorised
Myocet

doxorubicin hydrochloride

Breast Neoplasms 2000-07-13           Authorised
Perjeta

pertuzumab

Breast Neoplasms 2013-03-04           Authorised
Taxespira (previously Docetaxel Hospira UK Limited )

docetaxel trihydrate

Breast Neoplasms 2015-08-28           Authorised