European Public Assessment Reports

$79 / 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.

Complexity

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.

Date Created

2011

Last Modified

2018-03-23

Version

2018-03-23

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

European Economic Area Countries

Source

John Snow Labs => European Medicines Agency (EMA)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

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

Other Titles

EMA European Public Assessment Reports, European Medicines Agency EPARs

Name Description Type Constraints
Medicine_NameMedicine Namestringrequired : 1
Product_NumberThe product numberstringrequired : 1
Active_SubstanceActive substance namestringrequired : 1
Common_NameProduct common namestringrequired : 1
ATC_CodeAnatomical Therapeutic Chemical (ATC) codestring-
Marketing_Authorization_HolderMarketing authorization holder namestring-
StatusCurrent product statusstringenum : Array required : 1
Revision_NumberRevision numberintegerlevel : Ratio
Authorization_DateAuthorization datedate-
IndicationProduct indicationstring-
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_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
Is_GenericIndicate if the product is a genericbooleanrequired : 1
Is_BiosimilarIndicate if the product is a biosimilarbooleanrequired : 1
Medicine_NameProduct_NumberActive_SubstanceCommon_NameATC_CodeMarketing_Authorization_HolderStatusRevision_NumberAuthorization_DateIndicationIs_Condition_ApprovalIs_Exceptional_CircumstanceIs_OrphanIs_GenericIs_Biosimilar
ImpulsorEMEA/H/C/001122milnacipranmilnacipranPierre Fabre MedicamentRefused0falsefalsefalsefalsefalse
ThymanaxEMEA/H/C/000657agomelatineagomelatineLes Laboratoires ServierRefused0falsefalsefalsefalsefalse
ValdoxanEMEA/H/C/000656agomelatineagomelatineLes Laboratoires ServierRefused0falsefalsefalsefalsefalse
GemesisEMEA/H/C/000997becaplerminbecaplerminBioMimetic Therapeutics LtdRefused0falsefalsefalsefalsefalse
QsivaEMEA/H/C/002350phentermine / topiramatephentermine / topiramateVivus BVRefused0falsefalsefalsefalsefalse
GenasenseEMEA/H/C/000711oblimersenoblimersenGenta Development Ltd. c/o Ross & CraigRefused0falsefalsefalsefalsefalse
MasiproEMEA/H/C/004159masitinib mesylatemasitinibL01XE22AB ScienceRefused0Treatment of mastocytosisfalsefalsetruefalsefalse
SovrimaEMEA/H/C/000908idebenoneidebenoneN06BX13Centocor B.V.Refused0Treatment of Friedreichs Ataxiafalsefalsetruefalsefalse
Sumatriptan GalpharmEMEA/H/C/002140sumatriptan succinatesumatriptanGalpharm Healthcare Ltd.Refused0falsefalsefalsetruefalse
NerventraEMEA/H/C/002546laquinimodlaquinimodN07Teva Pharma GmbHRefused0Treatment of multiple sclerosisfalsefalsefalsefalsefalse