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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

rosiglitazone / metformin hydrochloride,

Diabetes Mellitus, Type 2 2003-10-20           Withdrawn
Competact

pioglitazone / metformin hydrochloride

Diabetes Mellitus, Type 2 2006-07-28           Authorised
Ebymect

dapagliflozin propanediol monohydrate / metformin hydrochloride

Diabetes Mellitus, Type 2 2015-11-16           Authorised
Efficib

sitagliptin / metformin hydrochloride

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

vildagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2007-11-14           Authorised
Glubrava

metformin hydrochloride / pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2007-12-11           Authorised
Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

vildagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2008-12-01           Authorised
Janumet

sitagliptin / metformin hydrochloride

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

linagliptin / metformin

Diabetes Mellitus, Type 2 2012-07-20           Authorised
Komboglyze

metformin hydrochloride / saxagliptin hydrochloride

Diabetes Mellitus, Type 2 2011-11-24           Authorised
Ristfor

sitagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2010-03-15           Authorised
Synjardy

empagliflozin / metformin

Diabetes Mellitus, Type 2 2015-05-27           Authorised
Velmetia

sitagliptin / metformin hydrochloride

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

alogliptin benzoate / metformin hydrochloride

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

canagliflozin / metformin hydrochloride

Diabetes Mellitus, Type 2 2014-04-23           Authorised
Xigduo

metformin hydrochloride / dapagliflozin propanediol monohydrate

Diabetes Mellitus, Type 2 2014-01-16           Authorised
Zomarist

vildagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2008-12-01           Authorised