Referral: Havrix, hepatitis A virus (inactivated, adsorbed), associated names: Havrix and associated names, Article 30 referrals, Under evaluation, 14/09/2023, 10/11/2023
Opinion/decision on a Paediatric investigation plan (PIP): 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol, decision type: , therapeutic area: , PIP number: P/0479/2022
Academia Info Day, European Medicines Agency, Amsterdam, 09:30 - 13:30 (CET), from 10/11/2023 to 10/11/2023
Opinion/decision on a Paediatric investigation plan (PIP): Obefazimod, decision type: , therapeutic area: , PIP number: P/0519/2022
Getting ready for EMA’s website relaunch on 5 December 2023
We are pleased to announce that we have opened the call for the host selection of the ESIM 2025 - 2026/27 summer school.
National Societies wishing to host ESIM should submit their application to EFIM Secretariat on info@efim.org or aneta.trajkovska@efim.org that should include the following essential information:
Opinion/decision on a Paediatric investigation plan (PIP): Methylphenidate (hydrochloride), decision type: , therapeutic area: , PIP number: P/0057/2023
Opinion/decision on a Paediatric investigation plan (PIP): Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab), decision type: , therapeutic area: , PIP number: P/0017/2023
Opinion/decision on a Paediatric investigation plan (PIP): Evoncabtagene pazurgedleucel, decision type: , therapeutic area: , PIP number: P/0016/2023
Opinion/decision on a Paediatric investigation plan (PIP): Neisseria meningitidis serogroup B fHbp subfamily A,Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein,Neisseria meningitidis serogroup B fHbp subfamily B,Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein,Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein,Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY), decision type: , therapeutic area: , PIP number: P/005