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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-100117-PIP01-21-M01 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100145-PIP01-21-M01 (update)	BRIGATINIB	Non small cell lung cancer Anaplastic large cell lymphoma Inflammatory myofibroblastic tumours	Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100166-PIP01-21-M01 (update)	ENTRECTINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100252-PIP01-21-M01 (update)	GEMTUZUMAB OZOGAMICIN	Treatment of acute myeloid leukaemia	Mylotarg Mylotarg 16/06/2019 Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100494-PIP01-22-M01 (update)	NIVOLUMAB	Malignant neoplasms of lymphoid tissue Malignant neoplasms of the central nervous system	OPDIVO OPDIVO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100158-PIP01-21-M01 (update)	PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Keytruda Keytruda	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100240-PIP01-21-M01 (update)	BOSUTINIB	Treatment of chronic myeloid leukaemia (CML)	Bosulif Bosulif	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100238-PIP01-21-M01 (update)	AVELUMAB	Treatment of malignant neoplasms of the CNS, lymphoid tissue and other malignant neoplasms.	Bavencio Bavencio Bavencio Bavencio Bavencio	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100260-PIP01-21-M01 (update)	CEMIPLIMAB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Libtayo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100233-PIP01-21-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cabometyx Cometriq Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Aptimetyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cometriq Cabometyx Cometriq Cabometyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100377-PIP01-21-M01 (update)	ACALABRUTINIB	Treatment of mature B cell neoplasms	calquence calquence	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100352-PIP01-21-M01 (update)	AVAPRITINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100200-PIP01-21-M01 (update)	REGORAFENIB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Stivarga Stivarga	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		04/11/2022
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

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