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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100117-PIP01-21-M03 (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.	Yes		30/01/2024
MHRA-100950-PIP01-23	lutetium-177 (177Lu) rhPSMA 10.1	Treatment of prostate cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/01/2024
MHRA-100872-PIP01-23	pudexacianinium chloride	Visualisation of ureter		Uro-Nephrology Gastroenterology-Hepatology Diagnostic Endocrinology-Gynaecology-Fertility-metabolism Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/01/2024
MHRA-101058-PIP01-23	SIROLIMUS	Treatment of Tuberous Sclerosis	Pascomer	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	30/01/2024
MHRA-100866-PIP01-23	obecabtagene autoleucel	Treatment of acute lymphoblastic leukaemia (ALL)		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/01/2024
MHRA-100991-PIP01-23	Maralixibat chloride	Treatment of progressive familial intrahepatic cholestasis (PFIC)	LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/01/2024
MHRA-100593-PIP01-22	aticaprant	Treatment of Major Depressive Disorder	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/01/2024
MHRA-101016-PIP01-23	ublituximab	Treatment of multiple sclerosis	Briumvi Briumvi	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		20/12/2023
MHRA-101024-PIP01-23-M01 (update)	gadoquatrane	Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging		Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
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-100932-PIP01-23-M02 (update)	Defatted powder of peanuts	Treatment of peanut allergy	Palforzia Palforzia Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100932-PIP01-23-M01 (update)	Peanut Flour	Treatment of peanut allergy	Palforzia PALFORZIA Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100188-PIP01-21-M02 (update)	lebrikizumab	treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101028-PIP01-23-M01 (update)	Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)	Prevention of cholera	Vaxchora	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100642-PIP01-22-M02 (update)	Tremelimumab	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).	IMJUDO Tremelimumab AstraZeneca	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-101004-PIP01-23-M01 (update)	APIXABAN	Treatment of venous thromboembolism	Eliquis Eliquis Eliquis Eliquis	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100949-PIP01-23-M01 (update)	Delandistrogene moxeparvovec	Treatment of Duchenne muscular dystrophy	Not available	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100482-PIP01-22-M01 (update)	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick disease type C	Not available at present	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100141-PIP01-21-M01 (update)	BENRALIZUMAB	Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA FASENRA PEN	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101117-PIP01-23-M01 (update)	ORITAVANCIN	Treatment of acute bacterial skin and skin structure infections (ABSSSI)	Tenkasi Tenkasi Orbactiv Tenkasi Tenkasi	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023

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