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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-100444-PIP01-22-M01 (update)	ETELCALCETIDE	Treatment of hyperparathyroidism	Parsabiv Parsabiv	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100447-PIP01-22-M01 (update)	tirzepatide	Treatment of Type 2 Diabetes Mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100455-PIP01-22-M01 (update)	IXAZOMIB	Treatment of multiple myeloma Treatment of lymphoid malignancies (excluding multiple myeloma)	Ninlaro Ninlaro Ninlaro Ninlaro	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100465-PIP01-22-M01 (update)	efanesoctocog alfa	Treatment of congenital haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100502-PIP01-22-M01 (update)	Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype) Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype) Recombinant Influenza Hemagglutinin-strain B (Victoria lineage) Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)	Prevention of influenza infection	Supemtek Supemtek	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		07/12/2022
MHRA-100492-PIP01-22-M01 (update)	MOLGRAMOSTIM	Treatment of pulmonary alveolar proteinosis	Not available at present	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100507-PIP01-22-M01 (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-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-100523-PIP01-22-M01 (update)	gadopiclenol	Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity	Not available at present	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100524-PIP01-22-M01 (update)	gadopiclenol	Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity	Not available at present	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100523-PIP01-22-M02 (update)	gadopiclenol	Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.	Elucirem Elucirem	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100524-PIP01-22-M02 (update)	gadopiclenol	Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes	Elucirem Elucirem	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100479-PIP01-22-M01 (update)	POSACONAZOLE	Prevention of invasive fungal infections Treatment of invasive fungal infections	Noxafil Noxafil Noxafil Noxafil Noxafil	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100479-PIP01-22-M02 (update)	POSACONAZOLE	Prevention of invasive fungal infections Treatment of invasive fungal infections	Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100535-PIP01-22-M01 (update)	UMECLIDINIUM BROMIDE FLUTICASONE FUROATE VILANTEROL TRIFENATATE	Treatment of asthma	Trelegy Ellipta Trelegy Ellipta/ Elebrato/Temybric Trelegy Ellipta	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100535-PIP01-22-M02 (update)	FLUTICASONE FUROATE UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE	Treatment of asthma	Trelegy Ellipta Trelegy Ellipta Trelegy Ellipta/ Elebrato Ellipta Trelegy Ellipta	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
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-100564-PIP01-22-M01 (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		07/12/2022
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-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

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