EMA Withdrawn Applications

$79 / year

The European Medicines Agency (EMA) Withdrawn Applications dataset includes information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a human medicine.
It includes withdrawals of new marketing authorization applications or for changes to existing marketing authorizations, which are evaluated by the Committee for Medicinal Products for Human Use (CHMP).

Complexity

The legal basis for the publication of information on the withdrawal of applications for marketing authorization for human medicinal products is Article 11 of Regulation EC 726/2004, which states that: “If an applicant withdraws an application for a Marketing Authorization submitted to the Agency before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the Agency.
The Agency shall make this information accessible and shall publish the assessment report, if available, after deletion of all information of commercially confidential nature”.
If an applicant withdraws an application after the CHMP has adopted a positive or negative opinion, but before the European Commission has issued a decision, the EMA will publish the relevant withdrawal documents described above, stating that the withdrawal occurred post-opinion.

Date Created

2011

Last Modified

2018-04-21

Version

2018-04-21

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European Medicines Agency, EMA Withdrawn, Applications Withdrawn

Other Titles

EMA Medicinal Products Withdrawn, European Medicines Agency Withdrawn Applications

Name Description Type Constraints
Medicine_NameMedicine Namestring-
International_Nonproprietary_Name_of_MedicineInternational nonproprietary name of medicinal product (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.stringrequired : 1
Date_Of_WithdrawalDate of application withdrawaldaterequired : 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
Withdrawn_TypeApplication withdrawn typestringenum : Array required : 1
Marketing_Authorization_HolderMarketing authorization holder namestring-
Medicine_NameInternational_Nonproprietary_Name_of_MedicineDate_Of_WithdrawalIs_OrphanWithdrawn_TypeMarketing_Authorization_Holder
Mersarexiclaprim2009-10-21falseInitial authorization-
Zactimavandetanib2009-10-27falseInitial authorization-
Egranlibalugrastim2014-11-04falseInitial authorization-
Adempasriociguat2016-08-11truePost-authorizationBayer AG
Sliwenseplivanserin2009-12-18falseInitial authorization-
Effentorafentanyl2013-07-11falsePost-authorizationTeva B.V.
Erbituxcetuximab2012-09-17falsePost-authorizationMerck KGaA
Topotecan SUNtopotecan2011-01-03falseInitial authorization-
Zavescamiglustat2008-02-19truePost-authorizationActelion Ltd
Opsiriasirolimus2016-05-20falseInitial authorizationSanten Oy