Human medicines European public assessment report (EPAR): Duloxetine Zentiva, duloxetine, Date of authorisation: 20/08/2015, Revision: 13, Status: Authorised

PSUSA/00010488/202405

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology;Immunology-Rheumatology-Transplantation, PIP number: P/0452/2023

Opinion/decision on a Paediatric investigation plan (PIP): Breyanzi, Lisocabtagene maraleucel, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0448/2023

Opinion/decision on a Paediatric investigation plan (PIP): Paxlovid, nirmatrelvir,nirmatrelvir / ritonavir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0447/2023

PSUSA/00010335/202404

PSUSA/00000574/202403

Orphan designation: pasireotide Treatment of acromegaly, 08/10/2009 Expired

Human medicines European public assessment report (EPAR): Signifor, pasireotide, Date of authorisation: 24/04/2012, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Ketoconazole HRA, ketoconazole, Date of authorisation: 18/11/2014, Revision: 10, Status: Authorised