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Displaying 761 - 773 of 773

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort ascending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100564-PIP01-22-M02 (update)	TEDIZOLID PHOSPHATE	Treatment of acute bacterial skin and skin structure infections	Sivextro Sivextro Sivextro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100543-PIP01-22-M02 (update)	DOLUTEGRAVIR LAMIVUDINE	Treatment of Human Immunodeficiency virus (HIV - 1) Infection	Dovato Dovato Dovato	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101212-PIP01-23-M01 (update)	CEFEPIME DIHYDROCHLORIDE MONOHYDRATE enmetazobactam	Treatment of infections caused by gram-negative organisms	EXBLIFEP	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/04/2024
MHRA-100195-PIP01-21-M04 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluxa Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-100143-PIP01-21-M02 (update)	TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of chronic viral hepatitis B	Vemlidy Vemlidy Vemlidy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100164-PIP01-21-M03 (update)	Nirmatrelvir RITONAVIR	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101162-PIP01-23-M01 (update)	LETERMOVIR	Prevention of cytomegalovirus infection	PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PRVEYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS tablet PREVYMIS	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-100564-PIP01-22-M03 (update)	TEDIZOLID PHOSPHATE	Treatment of acute bacterial skin and skin structure infections	Sivextro Sivextro Sivextro Sivextro Sivextro Sivextro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		01/05/2024
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-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-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-100588-PIP01-22	UB-612	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present		P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100068-PIP01-21-M02 (update)	VEDOLIZUMAB	Treatment of Pouchitis	Entyvio Entyvio		PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024

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