Aprotinin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0030

Aprotinin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0030

Multi-annual artificial intelligence workplan 2023-2028: HMA-EMA joint Big Data Steering Group

Submission deadlines for paediatric applications 2024-2026

Orphan designation: H-L-tryphophanyl-L-seryl-glycyl-L-tryptophanyl-L-seryl-L-seryl-L-cysteinyl-L-seryl-L-arginyl-L-seryl-L-cysteinyl-glycyl-OH (disulfide bond), acetate salt Treatment of spinal cord injury, 15/02/2023 Positive

Orphan designation: adeno-associated viral vector serotype 9 expressing fukutin-related protein Treatment of limb girdle muscular dystrophy, 15/02/2023 Positive

Orphan designation: patidistrogene bexoparvovec Treatment of limb girdle muscular dystrophy, 15/02/2023 Positive

Human medicines European public assessment report (EPAR): Mixtard, insulin human (rDNA), Date of authorisation: 07/10/2002, Revision: 20, Status: Authorised

Orphan designation: melatonin Treatment of perinatal asphyxia, 15/02/2023 Positive

Veterinary medicines highlights 2023