Orphan designation: everolimus, Treatment of tuberous sclerosis, 04/08/2010, Expired
Summary of opinion: Takhzyro,lanadelumab, 14/09/2023, Positive
Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
Guideline on safety and efficacy data requirements for 4 applications for immunological veterinary medicinal 5 products intended for limited markets but not eligible 6 for authorisation under Article 23 of Regulation (EU) 7 2019/6
Summary of opinion: Kalydeco,ivacaftor, 14/09/2023, Positive
Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets
Summary of opinion: Vanflyta,quizartinib, 14/09/2023, Positive
Summary of opinion: Catiolanze,latanoprost, 14/09/2023, Positive
Summary of opinion: Voxzogo,vosoritide, 14/09/2023, Positive
User safety of topically administered products - Scientific guideline