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PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100116-PIP01-21-M01 (update)	TEZACAFTOR ELEXACAFTOR IVACAFTOR	Treatment of Cystic Fibrosis	Kaftrio Kaftrio Trikafta Kaftrio Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100116-PIP01-21-M02 (update)	IVACAFTOR TEZACAFTOR ELEXACAFTOR	Treatment of cystic fibrosis	Kaftrio Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Kaftrio Kaftrio Trikafta Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100844-PIP01-23-M01 (update)	IVACAFTOR	Treatment of cystic fibrosis.	Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco	Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	24/08/2023
MHRA-100147-PIP01-21-M01 (update)	OSELTAMIVIR PHOSPHATE	Treatment and prevention of influenza	Tamiflu Tamiflu Tamiflu	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		18/03/2022
MHRA-100156-PIP01-21-M01 (update)	FLUOCINOLONE ACETONIDE	Treatment of non-infectious uveitis Secondary prevention of non-infectious uveitis	ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru ILUVIEN Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammi impianto intravitreale in applicatore ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 microgram, intravitreaal implant in applicator Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze ILUVIEN 190 microgramas implante intravítreo em aplicador ILUVIEN 190 microgramos implante intravítreo en aplicador Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN fluocinolone acetonide 190 micrograms intravitreal implant in applicator	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		18/03/2022
MHRA-100157-PIP01-21-M01 (update)	EXENATIDE	Type 2 diabetes mellitus	Byetta Bydureon Bydureon BCise Byetta Byetta Bydureon Bydureon Byetta Bydureon	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	18/03/2022
MHRA-100168-PIP01-21-M01 (update)	Naloxegol (as naloxegol oxalate)	Treatment of opioid-induced constipation	Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		18/03/2022
MHRA-100392-PIP01-21-M01 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersio n for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/04/2022
MHRA-100391-PIP01-21-M01 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/04/2022
MHRA-100392-PIP01-21-M02 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100392-PIP01-21-M03 (update)	TOZINAMERAN TOZINAMERAN/ FAMTOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100390-PIP01-21-M01 (update)	Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2)	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/04/2022
MHRA-100276-PIP01-21-M01 (update)	BRODALUMAB	Treatment of psoriasis	brodalumab Lumicef Siliq Kyntheum	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		04/05/2022
MHRA-100276-PIP01-21-M02 (update)	BRODALUMAB	Treatment of psoriasis	Kyntheum Lumicef Siliq	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		24/08/2023
MHRA-100052-PIP01-21-M01 (update)	CASIRIVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		04/05/2022
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-100053-PIP01-21-M01 (update)	IMDEVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		04/05/2022
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-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-100467-PIP01-22-M01 (update)	SEMAGLUTIDE	Treatment of obesity	Ozempic Ozempic 0.25 mg, 0.5 mg, 1 mg	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023

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