CTIS newsflash - 1 September 2023

Human medicines European public assessment report (EPAR): Vumerity, diroximel fumarate, Multiple Sclerosis, Relapsing-Remitting, Date of authorisation: 15/11/2021, Revision: 4, Status: Authorised

LifeGlobal Media - Procedural steps and scientific information after initial consultation

Records of data processing activity for the user test of the Critical Medical Device Shortages (CMDS) system

Alitretinoin (oral use) : List of nationally authorised medicinal products - PSUSA/00010710/202301

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), COVID-19 virus infection, Date of authorisation: 30/03/2023, Revision: 2, Status: Authorised

LinkedIn Live interview with Ivo Claassen: Tomorrow's veterinary medicines for healthy animals and humans, Online, 13:15-13:45 Amsterdam time (CEST), from 07/09/2023 to 07/09/2023

Opinion/decision on a Paediatric investigation plan (PIP): Doptelet,Avatrombopag, decision type: , therapeutic area: , PIP number: P/0482/2020

Opinion/decision on a Paediatric investigation plan (PIP): (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4- fluoropyrrolidine-2-carboxamide (ACH-0144471), decision type: , therapeutic area: , PIP number: P/0243/2019

Human medicines European public assessment report (EPAR): Revolade, eltrombopag, Purpura, Thrombocytopenic, Idiopathic, Date of authorisation: 11/03/2010, Revision: 34, Status: Authorised