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Last updated about 1 hour ago

Report - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment

about 1 hour ago

Report - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models...

PSUSA/00000491/202506

about 2 hours ago

PSUSA/00000491/202506

Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Date of authorisation: 06/02/2009, Revision: 27, Status: Authorised

about 2 hours ago

Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Date of authorisation...

Member states contact points for translations review

about 2 hours 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

about 3 hours 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

about 3 hours ago

Human medicines European public assessment report (EPAR): Xigduo, dapagliflozin,metformin, Date of authorisation...

Standard operating procedure for the preparation of ESUAvet annual reports

about 3 hours 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

about 3 hours 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

about 3 hours 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)

about 3 hours 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

about 3 hours 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

about 3 hours ago

Contact details of national competent authorities for requests of translation exemptions falling...