Report - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment
PSUSA/00000491/202506
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Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin,metformin, Date of authorisation: 15/11/2015, Revision: 25, Status: Authorised
Human medicines European public assessment report (EPAR): Xigduo, dapagliflozin,metformin, Date of authorisation: 16/01/2014, Revision: 27, Status: Authorised
Standard operating procedure for the preparation of ESUAvet annual reports
Human medicines European public assessment report (EPAR): Dasselta, desloratadine, Date of authorisation: 28/11/2011, Revision: 14, Status: Authorised
Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
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