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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-101857-PIP01-25	Humanised afucosylated IgG1 monoclonal antibody against CCR8	Treatment of all conditions included in the category of malignant neoplasms except melanoma, nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		29/08/2025
MHRA-101641-PIP01-24	Japanese encephalitis virus, strain SA14-14-2, Live	Prevention of Japanese encephalitis	IMOJEV IMOJEV IMOJEV	Infectious diseases Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/08/2025
MHRA-101404-PIP01-24-M01 (update)	TRASTUZUMAB DERUXTECAN	Treatment of all conditions in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	Enhertu Enhertu	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/08/2025
MHRA-101356-PIP01-24-M01 (update)	inebilizumab	Treatment of myasthenia gravis	Uplizna Uplizna Uplizna Uplizna Uplizna Xinyue Uplizna Uplizna Uplizna Uplizna Uplizna Uplizna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/08/2025
MHRA-100145-PIP01-21-M02 (update)	BRIGATINIB	Treatment of non-small cell lung cancer (NSCLC) Treatment of anaplastic large cell lymphoma (ALCL) Treatment of Inflammatory myofibroblastic tumours		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/08/2025
MHRA-101908-PIP01-25-M01 (update)	MOSUNETUZUMAB	Treatment of mature B-cell neoplasms	Lunsumio	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/08/2025
MHRA-101447-PIP01-24-M02 (update)	DIFELIKEFALIN ACETATE	Treatment of chronic kidney disease associated pruritus.	Kapruvia Kapruvia	Other: Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/08/2025
MHRA-101916-PIP01-25	PF-07248144	Treatment of breast cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		29/08/2025
MHRA-101909-PIP01-25	5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one	Treatment of prostate malignant neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		29/08/2025
MHRA-100462-PIP01-22-M03 (update)	FENFLURAMINE HYDROCHLORIDE	Treatment of Dravet syndrome.	Fintepla Fintepla Fintepla Fintepla Fintepla	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/08/2025
MHRA-101159-PIP02-25	Sacituzumab Tirumotecan	Treatment of urothelial carcinoma	sac-TMT (佳泰莱®)	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		13/08/2025
MHRA-101984-PIP01-25	obicetrapib EZETIMIBE	Treatment of elevated cholesterol		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		13/08/2025
MHRA-101781-PIP01-25	pozelimab	Treatment of paroxysmal nocturnal haemoglobinuria	Veopoz	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		13/08/2025
MHRA-101782-PIP01-25	cemdisiran sodium	Treatment of paroxysmal nocturnal haemoglobinuria		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		13/08/2025
MHRA-101471-PIP01-24	Respiratory syncytial virus, prefusion F protein, virus-like particle; Human metapneumovirus, prefusion F protein, virus-like particle IVX-A12	Prevention of lower respiratory tract disease caused by respiratory syncytial virus Prevention of lower respiratory tract disease caused by human metapneumovirus	Not available	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		13/08/2025
MHRA-101995-PIP01-25-M01 (update)	ISOFLURANE	Sedation of mechanically ventilated patients	Sedaconda and associated names	Other: Sedation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	13/08/2025
MHRA-100447-PIP01-22-M03 (update)	Tirzepatide	Treatment of Type 2 diabetes mellitus.	Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro, Zepbound Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro Mounjaro, Zepbound	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	13/08/2025
MHRA-100289-PIP01-21-M04 (update)	GALCANEZUMAB	Prevention of migraine headaches.	Emgality Emgality 120 mg solution for injection in pre-filled syringe	Neurology Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		13/08/2025
MHRA-102010-PIP01-25	PEGCETACOPLAN	Treatment of geographic atrophy secondary to age related macular degeneration.	Syfovre Syfovre Syfovre Syfovre	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/07/2025
MHRA-101021-PIP01-23-M03 (update)	FILGOTINIB MALEATE	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)	Jyseleca	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		28/07/2025

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