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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

amlodipine besilate / valsartan

Hypertension 2016-03-22           Authorised
Aprovel

irbesartan

Hypertension 1997-08-27           Authorised
CoAprovel

irbesartan / hydrochlorothiazide

Hypertension 1998-10-15           Authorised
Copalia

amlodipine (as besylate) / valsartan

Hypertension 2007-01-16           Authorised
Copalia HCT

amlodipine / valsartan / hydrochlorothiazide

Hypertension 2009-11-04           Authorised
Dafiro

amlodipine / valsartan

Hypertension 2007-01-16           Authorised
Dafiro HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Hypertension 2009-11-04           Authorised
Edarbi

azilsartan medoxomil

Hypertension 2011-12-07           Authorised
Exforge

amlodipine (as besylate) / valsartan

Hypertension 2007-01-17           Authorised
Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Hypertension 2009-10-16           Authorised
Ifirmacombi

irbesartan / hydrochlorothiazide

Hypertension 2011-03-04           Authorised
Ifirmasta (previously Irbesartan Krka)

irbesartan hydrochloride

Hypertension 2008-12-01           Authorised
Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)

irbesartan / hydrochlorothiazide

Hypertension 2007-01-19           Authorised
Irbesartan Teva

irbesartan

Hypertension 2009-10-30           Authorised
Irbesartan Zentiva (previously Irbesartan Winthrop)

irbesartan

Hypertension 2007-01-19           Authorised
Irbesartan/Hydrochlorothiazide Teva

irbesartan / hydrochlorothiazide

Hypertension 2009-11-26           Authorised
Karvea

irbesartan

Hypertension 1997-08-27           Authorised
Karvezide

irbesartan / hydrochlorothiazide

Hypertension 1998-10-16           Authorised
Kinzalkomb

telmisartan / hydrochlorothiazide

Hypertension 2002-04-19           Authorised
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)

telmisartan

Hypertension 1998-12-16           Authorised
Micardis

telmisartan

Hypertension 1998-12-16           Authorised
MicardisPlus

telmisartan / hydrochlorothiazide

Hypertension 2002-04-19           Authorised
Pritor

telmisartan

Hypertension 1998-12-11           Authorised
PritorPlus

telmisartan / hydrochlorothiazide

Hypertension 2002-04-22           Authorised
Rasilez

aliskiren

Hypertension 2007-08-22           Authorised