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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100698-PIP01-22	Nemvaleukin Alfa	Treatment of all conditions included in the category of malignant neoplasms (except CNS, haematopoietic and lymphoid tissue) Treatment of malignant neoplasms of the lymphoid tissue		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-101118-PIP01-23	5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7	Treatment of head and neck squamous cell carcinoma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100442-PIP01-22-M02 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-100485-PIP01-22-M02 (update)	AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide	Treatment of acute myeloid leukaemia	Tapotoclax	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101078-PIP01-23-M01 (update)	OLAPARIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).	Lynparza Lynparza Lynparza Lynparza Lynparza Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101123-PIP01-23-M01 (update)	BREXUCABTAGENE AUTOLEUCEL	Treatment of acute lymphoblastic leukaemia	Brexucabtagene autoleucel Brexucabtagene autoleucel Brexucabtagene autoleucel	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100240-PIP01-21-M04 (update)	BOSUTINIB	Treatment of chronic myeloid leukemia	Bosulif Bosulif	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-101249-PIP01-23-M01 (update)	Tovorafenib	Treatment of paediatric low grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		01/05/2024
MHRA-100296-PIP01-21-M01 (update)	palovarotene	Treatment of fibrodysplasia ossificans progressiva	SOHONOS	Other: Musculo-skeletal	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100340-PIP01-21-M01 (update)	LANADELUMAB	Prevention of hereditary angioedema attacks	TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		07/12/2022
MHRA-100340-PIP01-21-M02 (update)	LANADELUMAB	Prevention of hereditary angioedema attacks	TAKHZYRO TAKZHYRO TAKZHRYO TAKHZYRO TAKHZYRO TAKHZYRO TAKZHYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100832-PIP01-23-M01 (update)	LANADELUMAB	Prevention of attacks of idiopathic non-histaminergic angioedema (INHA).	TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/08/2023
MHRA-100503-PIP01-22	efavaleukin alfa	Treatment of ulcerative colitis	Not available at present	Other: Inflammatory Bowel Disease	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100811-PIP01-22	Vamorolone	Treatment of Duchenne muscular dystrophy	AGAMREE	Other: Neuromuscular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100811-PIP01-22-M01 (update)	Vamorolone	Treatment of Duchenne muscular dystrophy		Other: Neuromuscular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100274-PIP01-21-M02 (update)	ELIGLUSTAT	Treatment of Gaucher Disease Type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100274-PIP01-21-M01 (update)	ELIGLUSTAT	Treatment of Gaucher Disease type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100630-PIP01-22-M01 (update)	PATIROMER SORBITEX CALCIUM	Treatment of hyperkalaemia	Veltassa	Other: Nephrology/Metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100532-PIP01-22-M02 (update)	BUROSUMAB	Treatment of X-linked Hypophosphataemia	Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita	Other: musculoskeletal disorder; osteology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100681-PIP01-22	Lomitapide	Treatment of (heterozygous or homozygous) familial hypercholesterolaemia	Lojuxta hard capsule	Other: Hypercholesterolaemia (HoFH)	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023

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