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	2020-07-20
Version	2020-07-20
Update Frequency	Irregular
Temporal Coverage	N/A
Spatial Coverage	European Economic Area Countries
Source	John Snow Labs; European Medicines Agency (EMA);
Source License URL
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Keywords	European Medicines Agency, EMA Withdrawn, Applications Withdrawn
Other Titles	EMA Medicinal Products Withdrawn, European Medicines Agency Withdrawn Applications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
Category	Value: Human, Veterinary	string	-
Medicine_Name	Medicine Name	string	-
Active_Substance	Active substance 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	-
Therapeutic_Area	Product therapeutic area	string	-
Is_Patient_Safety	Indicate if the product is concerned by a patient safety information	boolean	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
Marketing_Authorization_Holder	Marketing authorization holder name	string	-
Is_Withdrawn_Type	Application withdrawn type (true = Initial authorisation and false = Post-authorisation)	boolean	-
Date_Of_Withdrawal	Date of application withdrawal	date	required : 1
Species	Veterinary species	string	-
First_Published	Date of first publication	date	-
Revision_Date	Date of revision	date	-
EMA_Link	URL of the product at EMA website	string	-

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