Agenda of the CHMP meeting 16-19 September 2024
Submitted by Anonymous (not verified) on 20 September 2024 - 13:00
Agenda of the CHMP meeting 16-19 September 2024
Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6 - Scientific guideline
Submitted by Anonymous (not verified) on 20 September 2024 - 13:00
Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6 - Scientific guideline
Withdrawn application: Sialanar, 06/09/2024
Submitted by Anonymous (not verified) on 20 September 2024 - 12:00
Withdrawn application: Sialanar, 06/09/2024
Summary of opinion: Fasenra, 19/09/2024 Positive
Submitted by Anonymous (not verified) on 20 September 2024 - 12:00
Summary of opinion: Fasenra, 19/09/2024 Positive
Summary of opinion: Dupixent, 19/09/2024 Positive
Submitted by Anonymous (not verified) on 20 September 2024 - 12:00
Summary of opinion: Dupixent, 19/09/2024 Positive
Summary of opinion: Zavicefta, 19/09/2024 Positive
Submitted by Anonymous (not verified) on 20 September 2024 - 12:00
Summary of opinion: Zavicefta, 19/09/2024 Positive
Clinical Trial Information System (CTIS) evaluation timelines
Submitted by Anonymous (not verified) on 20 September 2024 - 12:00
Clinical Trial Information System (CTIS) evaluation timelines
Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
Submitted by Anonymous (not verified) on 20 September 2024 - 11:40
Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
Submitted by Anonymous (not verified) on 20 September 2024 - 11:30
Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
Summary of opinion: Yurvac RHD, 12/09/2024 Positive
Submitted by Anonymous (not verified) on 20 September 2024 - 11:03
Summary of opinion: Yurvac RHD, 12/09/2024 Positive