Summary of opinion: Suvaxyn PRRS MLV, 19/06/2024 Positive
Submitted by Anonymous (not verified) on 21 June 2024 - 13:37
Summary of opinion: Suvaxyn PRRS MLV, 19/06/2024 Positive
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June 2024
Submitted by Anonymous (not verified) on 21 June 2024 - 13:37
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June 2024
GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)
Submitted by Anonymous (not verified) on 21 June 2024 - 12:30
GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)
List of centrally authorised products requiring a notification of a change for update of annexes
Submitted by Anonymous (not verified) on 21 June 2024 - 12:22
List of centrally authorised products requiring a notification of a change for update of annexes
Veterinary medicines European public assessment report (EPAR): Sileo, dexmedetomidine, Status: Authorised
Submitted by Anonymous (not verified) on 21 June 2024 - 12:10
Veterinary medicines European public assessment report (EPAR): Sileo, dexmedetomidine, Status: Authorised
Rules for the implementation of Council Regulation (EC) No 29795 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 May 2024
Submitted by Anonymous (not verified) on 21 June 2024 - 12:00
Rules for the implementation of Council Regulation (EC) No 29795 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 May 2024
Dates of 2025 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests
Submitted by Anonymous (not verified) on 21 June 2024 - 11:37
Dates of 2025 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests
Human medicines European public assessment report (EPAR): Prialt, ziconotide, Date of authorisation: 21/02/2005, Revision: 31, Status: Authorised
Submitted by Anonymous (not verified) on 21 June 2024 - 10:24
Human medicines European public assessment report (EPAR): Prialt, ziconotide, Date of authorisation: 21/02/2005, Revision: 31, Status: Authorised
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 21 June 2024 - 8:20
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 21 June 2024 - 8:20
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure