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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.

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 20/10/2003           Suspended
Competact

pioglitazone / metformin hydrochloride

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

dapagliflozin propanediol monohydrate / metformin hydrochloride

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

sitagliptin / metformin hydrochloride

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

vildagliptin / metformin hydrochloride

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

metformin hydrochloride / pioglitazone hydrochloride

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

vildagliptin / metformin hydrochloride

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

sitagliptin / metformin hydrochloride

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

linagliptin / metformin

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

metformin hydrochloride / saxagliptin hydrochloride

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

sitagliptin / metformin hydrochloride

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

empagliflozin / metformin

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

sitagliptin / metformin hydrochloride

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

alogliptin benzoate / metformin hydrochloride

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

canagliflozin / metformin hydrochloride

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

metformin hydrochloride / dapagliflozin propanediol monohydrate

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

vildagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 01/12/2008           Authorised