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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-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
MHRA-100335-PIP01-21-M01 (update)	Erdafitinib	Treatment of all conditions included in the category of malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue neoplasm)	BALVARSA BALVERSA ERFANDEL tablet BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100711-PIP01-22-M01 (update)	TISAGENLECLEUCEL	Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma	Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion Kymriah Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100567-PIP01-22-M01 (update)	Dinutuximab beta	Treatment of neuroblastoma	Qarziba Qarziba	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100580-PIP01-22-M01 (update)	CEMIPLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Cemiplimab	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100716-PIP01-22-M01 (update)	RUXOLITINIB PHOSPHATE	Treatment of chronic Graft versus Host Disease	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	30/06/2023
MHRA-100959-PIP01-23-M01 (update)	DOSTARLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).	Jemperli Jemperli Jemperli	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023
MHRA-100148-PIP01-21-M03 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma	Lenvima Lenvima Kisplyx Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023

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