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PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100332-PIP01-21	sotatercept	Treatment of pulmonary arterial hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100332-PIP01-21-M01 (update)	sotatercept	Treatment of pulmonary arterial hypertension	Not available at present	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		24/08/2023
MHRA-100454-PIP01-22	adagrasib	Treatment of all solid and haematological malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		27/09/2022
MHRA-100473-PIP01-22	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100487-PIP01-22	exebacase	Treatment of Staphylococcus aureus bacteraemia		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100162-PIP01-21-M01 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100162-PIP01-21-M02 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100197-PIP01-21-M01 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	27/09/2022
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-100136-PIP01-21	PEMBROLIZUMAB quavonlimab	All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		27/09/2022
MHRA-100125-PIP01-21	PEMBROLIZUMAB vibostolimab	Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma) Malignant CNS neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		27/09/2022
MHRA-100874-PIP01-23	PEMBROLIZUMAB	Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue) Treatment of Hodgkin lymphoma	Keytruda	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
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-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-100258-PIP01-21-M01 (update)	Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus	Not available yet	Infectious diseases	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-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-100182-PIP01-21-M01 (update)	Avalglucosidase alfa	Treatment of Pompe disease		Endocrinology-Gynaecology-Fertility-metabolism	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

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