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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort ascending	Date Published
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-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-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-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-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-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-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-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-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-100421-PIP01-22	efavaleukin alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
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-100087-PIP01-21-M02 (update)	LACOSAMIDE	Treatment of generalised epilepsy and epileptic syndromes.		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
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
MHRA-100695-PIP01-22-M01 (update)	Etranacogene dezaparvovec	Treatment of haemophilia B	Hemgenix	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100579-PIP01-22-M01 (update)	Maribavir	Treatment of cytomegalovius (CMV) infection	Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100579-PIP01-22-M02 (update)	Maribavir	Treatment of cytomegalovius (CMV) infection	Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100093-PIP01-21-M02 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100118-PIP01-21-M02 (update)	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100471-PIP01-22-M01 (update)	SETMELANOTIDE	Treatment of appetite and general nutrition disorders	IMCIVREE IMCIVREE IMCIVREE IMCIVREE	Nutrition	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100406-PIP01-21-M01 (update)	Marstacimab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023

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