Orphan designation: Mibavademab Treatment of Berardinelli-Seip syndrome (congenital generalised lipodystrophy), 21/03/2024 Positive

Orphan designation: Autologous CD3-positive T-cells expressing a chimeric antigen receptor against B cell maturation agent Treatment of multiple myeloma, 21/03/2024 Positive

New product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC

EMEA-003369-PIP01-22

EMEA-003366-PIP01-22

EMEA-003358-PIP01-22

Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Date of authorisation: 29/05/2006, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR): Byannli (previously Paliperidone Janssen-Cilag International), paliperidone, Date of authorisation: 18/06/2020, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen), paliperidone, Date of authorisation: 05/12/2014, Revision: 13, Status: Authorised

EMEA-003353-PIP01-22