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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-100455-PIP01-22-M01 (update)	IXAZOMIB	Treatment of multiple myeloma Treatment of lymphoid malignancies (excluding multiple myeloma)	Ninlaro Ninlaro Ninlaro Ninlaro	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100148-PIP01-21-M02 (update)	LENVATINIB MESILATE	Malignant neoplasms except haematopoietic, lymphoid, papillary & follicular thyroid, &osteosarcoma	Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100522-PIP01-22-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cometriq Cabometyx Cabometyx Cometriq	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100501-PIP01-22-M01 (update)	INOTUZUMAB OZOGAMICIN	Treatment of B cell acute lymphoblastic leukaemia	Besponsa Besponsa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100623-PIP01-22-M01 (update)	NIRAPARIB TOSYLATE MONOHYDRATE	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).	Zejula Zejula Zejula Zejula	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100254-PIP01-21-M01 (update)	epcoritamab	Treatment of mature B-cell malignancies	Not available at present	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100418-PIP01-22-M01 (update)	axicabtagene ciloleucel	Treatment of mature B-cell neoplasms	Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100031-PIP01-21-M02 (update)	PALBOCICLIB	Treatment of Ewing sarcoma (EWS)	Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance blisters in an outer carton/21 and 63 tablets Ibrance	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100442-PIP01-22-M01 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100025-PIP01-21-M02 (update)	LAROTRECTINIB	Treatment of malignant neoplasms of the central nervous system	VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100485-PIP01-22-M01 (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		25/05/2023
MHRA-100505-PIP01-22-M01 (update)	copanlisib dihydrochloride	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) Treatment of mature B-cell neoplasms	Aliqopa Aliqopa Aliqopa Aliqopa Aliqopa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100496-PIP01-22-M01 (update)	RUXOLITINIB PHOSPHATE	Treatment of acute Graft versus Host Disease (aGvHD)	Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100761-PIP01-22-M01 (update)	NIVOLUMAB relatlimab	Treatment of melanoma	Opdualag Opdualag Opdualag Opdualag	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100609-PIP01-22-M01 (update)	LENVATINIB MESILATE	Treatment of papillary thyroid cancer and follicular thyroid cancer Treatment of osteosarcoma	Lenvima Kisplyx Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100240-PIP01-21-M02 (update)	BOSUTINIB	Treatment of chronic myeloid leukaemia (CML)	Bosulif	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100117-PIP01-21-M02 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100674-PIP01-22-M01 (update)	DARATUMUMAB	Treatment of lymphoid malignancies (except mature B-cell neoplasms)	Darzalex Darzalex	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100641-PIP01-22-M01 (update)	DURVALUMAB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)	IMFINZI IMFINZI IMFINZI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100642-PIP01-22-M01 (update)	Tremelimumab	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).	IMJUDO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023

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