Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1), Treatment of hypoparathyroidism, 19/10/2020, Positive

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2023

Summary of opinion: Aqumeldi,Enalapril maleate, 14/09/2023, Positive

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023

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