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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100648-PIP01-22-M01 (update)	TECOVIRIMAT MONOHYDRATE	Treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia)	Tecovirimat SIGA Tecovirimat SIGA TPOXX	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100636-PIP01-22-M01 (update)	Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain	Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV)			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-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-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-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-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-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-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-100557-PIP01-22-M01 (update)	Hepatitis B (rDNA) surface antigen adjuvanted	Prevention of hepatitis B virus infection	HEPLISAV B HEPLISAV-B HEPLISAV-B HEPLISAV B	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	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-100028-PIP01-21-M01 (update)	TIXAGEVIMAB CILGAVIMAB	Prevention of Coronavirus Disease 2019 (COVID-19) Treatment of COVID-19	Evusheld Evusheld Evusheld	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100511-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of Crohn's disease	TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100476-PIP01-22	Anti-(alpha-synuclein) human monoclonal antibody	Treatment of Multiple System Atrophy Treatment of Parkinson's Disease		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100481-PIP01-22	TUCATINIB	Treatment of solid tumours	Tukysa	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100404-PIP01-21	insulin icodec SEMAGLUTIDE	Treatment of type 2 diabetes mellitus		Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022

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