Summary of opinion: Zoonotic Influenza Vaccine Seqirus,zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), 14/09/2023, Positive
Summary of opinion: Herwenda,trastuzumab, 14/09/2023, Positive
Referral: Mysimba, naltrexone, bupropion, Article 20 procedures, Procedure started
Summary of opinion: Kaftrio,ivacaftor,tezacaftor,elexacaftor, 14/09/2023, Positive
Summary of opinion: Ebglyss,Lebrikizumab, 14/09/2023, Positive
Summary of opinion: Olumiant,baricitinib, 14/09/2023, Positive
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 - Scientific guideline
Withdrawn application: Skycovion, GBP510, Date of withdrawal: 01/09/2023, Initial authorisation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