EMEA-003506-PIP01-23

Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0397/2024

Herbal medicinal product: Carvi fructus, Carum carvi L., F: Assessment finalised

Herbal medicinal product: Carvi aetheroleum, Carum carvi L., F: Assessment finalised

Opinion/decision on a Paediatric investigation plan (PIP): Paxlovid, nirmatrelvir,ritonavir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: EMA/PE/0000225184

Herbal medicinal product: Althaeae radix, Althaea officinalis L., F: Assessment finalised

Human medicines European public assessment report (EPAR): Tecartus, brexucabtagene autoleucel, Date of authorisation: 14/12/2020, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Date of authorisation: 23/08/2018, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Caprelsa, vandetanib, Date of authorisation: 16/02/2012, Revision: 30, Status: Authorised

Medicine shortage communication (MSC): Insulin lispro Sanofi (insulin lispro 100 units/ml solution for injection in cartridge and pre-filled pen)