Marketing Authorization (MA) has been approved in the following countries1):
Date of approval:
MA application has been submitted in the following countries1):
Date of submission:
A MA application has not yet been submitted, but is planned ,
in the following countries:
1) If the approved or applied indications in any of these countries differ from those given on the first page, please describe these differences in a separate enclosure.
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:
References, preferably the SmPC in English, should be enclosed.