Sixth Nitrosamine Implementation Oversight Group (NIOG) , from 07/12/2023 to 07/12/2023

Twelfth Nitrosamine Implementation Oversight Group (NIOG) meeting, from 06/12/2023 to 06/12/2023

Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate, decision type: , therapeutic area: , PIP number: P/0507/2022

Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, Date of authorisation: 18/10/2013, Revision: 15, Status: Authorised

Gemcitabine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001519/202301

Gemcitabine : List of nationally authorised medicinal products - PSUSA/00001519/202301

Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed,depigmented glutaraldehyde polymerised,alder pollen,birch pollen,hazel pollen, decision type: , therapeutic area: , PIP number: P/0548/2022

Opinion/decision on a Paediatric investigation plan (PIP): Mayzent,Siponimod (hemifumarate), decision type: , therapeutic area: , PIP number: P/0531/2022

Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed,depigmented glutaraldehyde polymerised,birch pollen, decision type: , therapeutic area: , PIP number: P/0527/2022

Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed,depigmented glutaraldehyde polymerised,birch pollen,alder pollen,hazel pollen, decision type: , therapeutic area: , PIP number: P/0526/2022