Procedures for monograph and list entry establishment
Submitted by Anonymous (not verified) on 11 December 2023 - 12:51
Procedures for monograph and list entry establishment
Expected publication dates of PRAC recommendations on safety signals
Submitted by Anonymous (not verified) on 11 December 2023 - 7:57
Expected publication dates of PRAC recommendations on safety signals
Summary of opinion: Frontpro (previously known as Afoxolaner Merial), 07/12/2023 Positive
Submitted by Anonymous (not verified) on 8 December 2023 - 15:00
Summary of opinion: Frontpro (previously known as Afoxolaner Merial), 07/12/2023 Positive
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 December 2023
Submitted by Anonymous (not verified) on 8 December 2023 - 14:30
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 December 2023
Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines
Submitted by Anonymous (not verified) on 8 December 2023 - 13:00
Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines
EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information
Submitted by Anonymous (not verified) on 8 December 2023 - 8:30
EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information
Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Date of authorisation: 14/11/2019, Revision: 5, Status: Withdrawn
Submitted by Anonymous (not verified) on 7 December 2023 - 15:17
Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Date of authorisation: 14/11/2019, Revision: 5, Status: Withdrawn
Orphan designation: Dersimelagon Treatment of erythropoietic protoporphyria, 16/03/2022 Positive
Submitted by Anonymous (not verified) on 7 December 2023 - 7:46
Orphan designation: Dersimelagon Treatment of erythropoietic protoporphyria, 16/03/2022 Positive
Data Quality Framework for EU medicines regulation
Submitted by Anonymous (not verified) on 6 December 2023 - 14:49
Data Quality Framework for EU medicines regulation
Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)
Submitted by Anonymous (not verified) on 6 December 2023 - 14:37
Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)