European Public Assessment Reports

$179 / year

The European Medicines Agency (EMA) publishes a European Public Assessment Report (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 authorized at a European Union level.


A European public assessment report (EPAR) is published for every human or veterinary medicine application that has been granted or refused a marketing authorization. This follows an assessment by the EMA of an application submitted by a pharmaceutical company in the framework of the Central authorization of medicines.
An EPAR provides public information on a medicine, including how it was assessed by the EMA.
The EPAR is referred to in Article 13(3) of Regulation (EC) No 726/2004, which requires the EMA to publish a public assessment report for each centrally authorized medicine together with a public-friendly summary.
The EMA has developed the EPAR concept over time to ensure that it delivers a usable, transparent and appropriately detailed body of information. The EPAR content and structure have therefore evolved over time and may be further developed in future.
An important role of the EPAR is to reflect the scientific conclusions of the relevant EMA committee at the end of the assessment process, providing the grounds for the committee opinion on whether or not to approve an application.
Under the centralized authorization procedure, pharmaceutical companies submit a single marketing-authorization application to EMA. This allows the marketing-authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization.
EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or no.
An orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for orphan designation are examined by the COMP, which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an orphan designation for the medicine in question.

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European Economic Area Countries


John Snow Labs; European Medicines Agency (EMA);

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European Medicines Agency, EMA Assessment Reports, Centralised Authorization Procedure, EMA Clinical DATA

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EMA European Public Assessment Reports, European Medicines Agency EPARs

CategoryValue: Human, Veterinarystringrequired : 1
Medicine_NameMedicine Namestringrequired : 1
Therapeutic_AreaProduct therapeutic areastring-
Common_NameProduct common namestringrequired : 1
Active_SubstanceActive substance namestringrequired : 1
Product_NumberThe product numberstringrequired : 1
Is_Patient_SafetyIndicate if the product is concerned by a patient safety informationbooleanrequired : 1
Authorisation_StatusCurrent product statusstringenum : Array required : 1
ATC_CodeAnatomical Therapeutic Chemical (ATC) codestring-
Is_Additional_MonitoringIndicate if the product is under additional monitoringbooleanrequired : 1
Is_GenericIndicate if the product is a genericbooleanrequired : 1
Is_BiosimilarIndicate if the product is a biosimilarbooleanrequired : 1
Is_Condition_ApprovalIndicate if the product is approved under specific conditions. Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.booleanrequired : 1
Is_Exceptional_CircumstanceIndicate if there were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.booleanrequired : 1
Is_Accelerated_AssessmentIndicate this medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210.booleanrequired : 1
Is_OrphanIndicate if the product has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.booleanrequired : 1
Marketing_Authorization_DateAuthorization datedate-
Refusal_DateDate of refusal of marketing authorisationdate-
Marketing_Authorization_HolderMarketing authorization holder namestring-
Human_Pharmacotherapeutic_GroupHuman pharmacotherapeutic group namestring-
Vet_Pharmacotherapeutic_GroupVeterinary pharmacotherapeutic group namestring-
Date_of_OpinionOpinion datedate-
Decision_DateDate of decisiondate-
Revision_NumberRevision numberintegerlevel : Ratio
IndicationProduct indicationstring-
SpeciesVeterinary speciesstring-
ATC_Vet_CodeAnatomical Therapeutic Chemical (ATC) veterinary codestring-
First_PublishedDate of first publicationdate-
Revision_DateDate of revisiondate-
EMA_LinkURL of the product at EMA websitestring-
HumanQsivaObesityphentermine / topiramatephentermine, topiramateEMEA/H/C/002350falseRefusedfalsefalsefalsefalsefalsefalsefalse2013-05-14Vivus BV2013-02-212013-05-1402013-05-142013-06-13
HumanImpulsorFibromyalgiamilnacipranmilnacipranEMEA/H/C/001122falseRefusedfalsefalsefalsefalsefalsefalsefalse2010-04-08Pierre Fabre Medicament2009-11-192010-04-2602010-04-262010-04-26
HumanGenasenseMelanomaoblimersenoblimersenEMEA/H/C/000711falseRefusedfalsefalsefalsefalsefalsefalsefalse2007-10-15Genta Development Ltd. c/o Ross Craig2007-07-192009-12-3102009-12-312009-12-31
HumanValdoxanDepressive Disorder, MajorAgomelatineAgomelatineEMEA/H/C/000656falseRefusedfalsefalsefalsefalsefalsefalsefalse2007-01-16Les Laboratoires Servier2006-07-272006-07-2702006-07-272006-07-27
HumanThymanaxDepressive Disorder, MajorAgomelatineAgomelatineEMEA/H/C/000657falseRefusedfalsefalsefalsefalsefalsefalsefalse2007-01-16Les Laboratoires Servier2006-07-272006-07-2702006-07-272006-07-27
HumanGemesisGuided Tissue Regeneration, PeriodontalbecaplerminbecaplerminEMEA/H/C/000997falseRefusedfalsefalsefalsefalsefalsefalsefalse2010-01-29BioMimetic Therapeutics Ltd2009-11-192009-11-2002009-11-202009-11-20
HumanNerventraMultiple SclerosislaquinimodlaquinimodEMEA/H/C/002546falseRefusedN07falsefalsefalsefalsefalsefalsefalse2014-08-19Teva Pharma GmbH2014-05-222013-12-200Treatment of multiple sclerosis,2013-12-202014-09-01
HumanSolumarvDiabetes Mellitusinsulin humaninsulin humanEMEA/H/C/003858falseRefusedA10AB01falsefalsetruefalsefalsefalsefalse2015-11-19Marvel Lifesciences Ltd2015-11-192016-02-110Treatment of diabetes2016-02-112016-02-16
HumanSumatriptan GalpharmMigraine Disorderssumatriptansumatriptan succinateEMEA/H/C/002140falseRefusedfalsetruefalsefalsefalsefalsefalse2012-02-09Galpharm Healthcare Ltd.2011-11-172012-02-0902012-02-092012-02-16
HumanElelysoGaucher Diseasetaliglucerase alfaTaliglucerase alfaEMEA/H/C/002250falseRefusedA16AB11falsefalsefalsefalsefalsefalsetrue2012-10-25Pfizer Ltd.   2012-07-032012-10-290treatment of Gaucher disease,2012-10-292012-11-23