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Keywords	European Medicines Agency, EMA Withdrawn, Applications Withdrawn
Other Titles	EMA Medicinal Products Withdrawn, European Medicines Agency Withdrawn Applications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_Name	Medicine Name	string	-
International_Nonproprietary_Name_of_Medicine	International 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.	string	required : 1
Date_Of_Withdrawal	Date of application withdrawal	date	required : 1
Is_Orphan	Indicate 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.	boolean	required : 1
Withdrawn_Type	Application withdrawn type	string	enum : Array required : 1
Marketing_Authorization_Holder	Marketing authorization holder name	string	-

Medicine_Name	International_Nonproprietary_Name_of_Medicine	Date_Of_Withdrawal	Is_Orphan	Withdrawn_Type	Marketing_Authorization_Holder
Mersarex	iclaprim	2009-10-21	false	Initial authorization	-
Zactima	vandetanib	2009-10-27	false	Initial authorization	-
Egranli	balugrastim	2014-11-04	false	Initial authorization	-
Adempas	riociguat	2016-08-11	true	Post-authorization	Bayer AG
Sliwens	eplivanserin	2009-12-18	false	Initial authorization	-
Effentora	fentanyl	2013-07-11	false	Post-authorization	Teva B.V.
Erbitux	cetuximab	2012-09-17	false	Post-authorization	Merck KGaA
Topotecan SUN	topotecan	2011-01-03	false	Initial authorization	-
Zavesca	miglustat	2008-02-19	true	Post-authorization	Actelion Ltd
Opsiria	sirolimus	2016-05-20	false	Initial authorization	Santen Oy

Others titles

Keywords

EMA Withdrawn Applications

Recent blog posts

Get to work

Need data?

Browse Data Market!

Need NLP?

Try Spark NLP

Need an AI Platform?

Schedule a Demo

Let’s Talk!