Opinion/decision on a Paediatric investigation plan (PIP): Lutathera, lutetium (177Lu) oxodotreotide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0461/2023

Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiac disorders, PIP number: P/0457/2023

Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol,mometasone, Date of authorisation: 30/05/2020, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Atectura Breezhaler, indacaterol,mometasone, Date of authorisation: 30/05/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Dynastat, parecoxib, Date of authorisation: 22/03/2002, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Zimbus Breezhaler, indacaterol,glycopyrronium,mometasone furoate, Date of authorisation: 03/07/2020, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Enerzair Breezhaler, indacaterol,glycopyrronium bromide,mometasone, Date of authorisation: 03/07/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Date of authorisation: 15/01/2001, Revision: 48, Status: Authorised