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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2012-04-20           Authorised
Capecitabine Medac

capecitabine

Colorectal Neoplasms 2012-11-19           Authorised
Capecitabine Teva

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2012-04-20           Authorised
Cyramza

ramucirumab

Stomach Neoplasms 2014-12-19           Authorised
Ecansya (previously Capecitabine Krka)

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2012-04-20           Authorised
Erbitux

cetuximab

Colorectal Neoplasms Head and Neck Neoplasms 2004-06-29           Authorised
Lonsurf

trifluridine / tipiracil hydrochloride

Colorectal Neoplasms 2016-04-25           Authorised
Stivarga

regorafenib

Colorectal Neoplasms 2013-08-26           Authorised
Vectibix

panitumumab

Colorectal Neoplasms 2007-12-03           Authorised
Xeloda

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2001-02-02           Authorised
Zaltrap

aflibercept

Colorectal Neoplasms 2013-02-01           Authorised