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
Human medicines European public assessment report (EPAR): Theralugand, lutetium (177Lu) chloride, Status: Opinion
Summary of opinion: Yurvac RHD, 12/09/2024 Positive
Human medicines European public assessment report (EPAR): Elahere, mirvetuximab soravtansine, Status: Opinion
Human medicines European public assessment report (EPAR): Hympavzi, Marstacimab, Status: Opinion
Human medicines European public assessment report (EPAR): Durysta, bimatoprost, Status: Withdrawn application (before opinion)
Summary of opinion: Aflunov, 19/09/2024 Positive
Summary of opinion: Otezla, 19/09/2024 Positive
Summary of opinion: Buccolam, 19/09/2024 Positive