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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-100352-PIP01-21-M02 (update)	AVAPRITINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100910-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of glioma Treatment of neuroblastoma	Verzenios Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100909-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of Ewing's sarcoma.	Verzenios Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100993-PIP01-23-M01 (update)	QUIZARTINIB DIHYDROCHLORIDE	Treatment of acute myeloid leukaemia (AML)	VANFLYTA VANFLYTA VANFLYTA	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100327-PIP01-21-M02 (update)	SELPERCATINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Retsevmo Retsevmo Retevmo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100409-PIP01-21-M01 (update)	autologous dendritic cells pulsed with autologous tumour cell lysate	Treatment of high grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100934-PIP01-23-M01 (update)	CARFILZOMIB	Treatment of acute lymphoblastic leukaemia	Kyprolis Kyprolis Kyprolis Kyprolis	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100985-PIP01-23-M01 (update)	BINIMETINIB	Treatment of melanoma	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100986-PIP01-23-M01 (update)	ENCORAFENIB	Treatment of melanoma	Braftovi Braftovi Bravtovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100840-PIP01-23-M01 (update)	Odronextamab	Treatment of mature B cell malignancies		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
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-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-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-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-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-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

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