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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-100519-PIP01-22	RSV preF protein	Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)			P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/02/2023
MHRA-100572-PIP01-22	autologous bone marrow-derived mononuclear cell enriched white blood cells	Treatment of chronic limb-threatening ischemia		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		02/02/2023
MHRA-100482-PIP01-22	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick Disease type C (NPC)		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/02/2023
MHRA-100469-PIP01-22	delgocitinib	Treatment of chronic hand eczema	no invented name yet	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/02/2023
MHRA-100297-PIP01-21	Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451)	Treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100574-PIP01-22	lixmabegagene relduparvovec	Treatment of GM1 gangliosidosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/02/2023
MHRA-100376-PIP01-21-M01 (update)	VEDOLIZUMAB	Treatment of Crohn's disease Treatment of Ulcerative colitis	Entyvio Entyvio Entyvio Entyvio	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		22/12/2022
MHRA-100556-PIP01-22	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022
MHRA-100458-PIP01-22	Modakafusp alfa	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022
MHRA-100135-PIP02-22	anti-CD40L humanised monoclonal antibody (SAR441344)	Treatment of progressive Multiple Sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		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-100053-PIP01-21 -M02 (update)	IMDEVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100052-PIP01-21-M02 (update)	CASIRIVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100507-PIP01-22-M02 (update)	BREXPIPRAZOLE	Treatment of schizophrenia	RXULTI RXULTI	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100600-PIP01-22-M01 (update)	Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)	Prevention of smallpox, monkeypox, related orthopoxvirus infection and disease	Imvanex Imvamune Jynneos	Vaccines	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-100608-PIP01-22-M01 (update)	mitapivat	Treatment of pyruvate kinase deficiency	PYRUKYND PYRUKYND	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100075-PIP01-21-M01 (update)	leniolisib	Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)	Joenja	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100601-PIP01-22-M01 (update)	elasomeran imelasomeran	Prevention of coronavirus disease 2019 (COVID-19)	Spikevax bivalent Original / Omicron Spikevax	Infectious diseases Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100566-PIP01-22-M01 (update)	MIRABEGRON	Treatment of neurogenic detrusor overactivity	BETMIGA BETMIGA MYRBETRIQ / MYRBETRIQ GRANULES	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022

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