Organisation chart: Information Management
Submitted by Anonymous (not verified) on 1 October 2024 - 14:03
Organisation chart: Information Management
Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3
Submitted by Anonymous (not verified) on 1 October 2024 - 12:58
Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3
Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline
Submitted by Anonymous (not verified) on 1 October 2024 - 12:58
Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline
Public statement on Esmya: Withdrawal of the marketing authorisation in the European Union
Submitted by Anonymous (not verified) on 1 October 2024 - 12:42
Public statement on Esmya: Withdrawal of the marketing authorisation in the European Union
Comirnaty : Periodic safety update report assessment 19 June 2023 to 18 December 2023
Submitted by Anonymous (not verified) on 27 September 2024 - 15:18
Comirnaty : Periodic safety update report assessment 19 June 2023 to 18 December 2023
Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Date of authorisation: 12/11/1996, Revision: 41, Status: Authorised
Submitted by Anonymous (not verified) on 27 September 2024 - 14:44
Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Date of authorisation: 12/11/1996, Revision: 41, Status: Authorised
Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
Submitted by Anonymous (not verified) on 27 September 2024 - 11:42
Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
Compilation of Union procedures on inspections and exchange of information
Submitted by Anonymous (not verified) on 26 September 2024 - 15:50
Compilation of Union procedures on inspections and exchange of information
Introduction to the Compilation of Union procedures on inspections and exchange of information
Submitted by Anonymous (not verified) on 26 September 2024 - 15:47
Introduction to the Compilation of Union procedures on inspections and exchange of information
EMA recommends suspension of sickle cell disease medicine Oxbryta
Submitted by Anonymous (not verified) on 26 September 2024 - 15:44
EMA recommends suspension of sickle cell disease medicine Oxbryta