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ATC DDD (Marketing authorization is needed)
Marketing Authorization (MA) has been approved in the following countries1)2): Date of approval:
MA application has been submitted in the following countries2): Date of submission:
A MA application has not yet been submitted, but is planned , in the following countries:
1) If the indication(s) in any country differ from those given in the application form, please describe these differences in a separate enclosure. 2) Please indicate type of application (e.g. National, Centralised Procedure, etc)
Documentation and references (e.g SPC/Prescribing information), in English only, should be uploaded on the next page. Please note that no paper copies are required when the application is submitted electronically followed by our automatic receipt. Application for ATC/DDD is free of charge.
Type 42 into this box:
Last updated: 2023-12-21