Technical validation YES NO, REQUESTED NO Technically Valid Extension Application Yes No qualitative change in Active substance not defined as a new active substance change of bioavailability change of pharmacokinetics In case of EA: change or addition of a new strength / potency Reason: change or addition of a new pharmaceutical form change or addition of a new route of administration Yes No National MA-No.: Existing MA in the MS: Comments: Is this application in accordance with the Guideline on the Yes No Categorisation of Extension Applications (EA) versus Variation Comments: Applications (V)
Technical validation YES NO, REQUESTED NO Technically Valid Extension Application Yes No In case of EA: Reason: qualitative change in Active substance not defined as a new active substance change of bioavailability change of pharmacokinetics change or addition of a new strength / potency change or addition of a new pharmaceutical form change or addition of a new route of administration Existing MA in the MS: Yes No National MA-No.: Comments: Is this application in accordance with the Guideline on the Categorisation of Extension Applications (EA) versus Variation Applications (V) Yes No Comments:
CMDh_368_2017_Rev01_12_2017.docx