Withdrawn application: Skycovion, GBP510, Date of withdrawal: 01/09/2023, Initial authorisation
Safety and efficacy data requirements for applications for immunological VMPs intended for limited markets but not eligible for authorisation under Art 23 of Reg (EU) 2019-6 - Scientific guideline
Summary of opinion: Nordimet,methotrexate, 14/09/2023, Positive
Summary of opinion: Adcetris,brentuximab vedotin, 14/09/2023, Positive
Summary of opinion: Enhertu,trastuzumab deruxtecan, 14/09/2023, Positive
Summary of opinion: Ryeqo,relugolix,estradiol,norethisterone acetate, 14/09/2023, Positive
Summary of opinion: Finlee,dabrafenib, 14/09/2023, Positive
Orphan designation: Dabrafenib mesylate, Treatment of glioma, 09/12/2020, Positive
Summary of opinion: Yorvipath,Palopegteriparatide, 14/09/2023, Positive
Summary of opinion: ZILBRYSQ,Zilucoplan, 14/09/2023, Positive