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Last updated 1 day ago
Report - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment
1 day ago
Report - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models...
Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Date of authorisation: 06/02/2009, Revision: 27, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Date of authorisation...
Member states contact points for translations review
1 day ago
Member states contact points for translations review
Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin,metformin, Date of authorisation: 15/11/2015, Revision: 25, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin,metformin, Date of authorisation...
Human medicines European public assessment report (EPAR): Xigduo, dapagliflozin,metformin, Date of authorisation: 16/01/2014, Revision: 27, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Xigduo, dapagliflozin,metformin, Date of authorisation...
Standard operating procedure for the preparation of ESUAvet annual reports
1 day ago
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
1 day ago
Human medicines European public assessment report (EPAR): Dasselta, desloratadine, Date of authorisation...
Human medicines European public assessment report (EPAR): HyQvia, human normal immunoglobulin, Date of authorisation: 16/05/2013, Revision: 26, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): HyQvia, human normal immunoglobulin, Date...
Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
1 day ago
Checklist for the submission of Day 215 product information annexes for a...
Member states contact points for review of national versions of the content of mobile scanning and other technologies
1 day ago
Member states contact points for review of national versions of the content...
Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
1 day ago
Contact details of national competent authorities for requests of translation exemptions falling...