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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort descending
MHRA-100336-PIP01-21-M01 (update)	soticlestat	Treatment of Dravet Syndrome Lennox-Gastaut Syndrome		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100349-PIP01-21-M01 (update)	Rezafungin acetate	Treatment of invasive candidiasis	Rezafungin 200 mg powder for concentrate for solution for infusion	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100237-PIP01-21-M01 (update)	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage) Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)	Prevention of influenza infection	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe) Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100428-PIP01-22-M01 (update)	Lenacapavir	Treatment of human immunodeficiency virus (HIV-1) infection		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100450-PIP01-22-M01 (update)	ALPELISIB	PIK3CA Related Overgrowth Spectrum (PROS)	Piqray Piqray	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100494-PIP01-22-M01 (update)	NIVOLUMAB	Malignant neoplasms of lymphoid tissue Malignant neoplasms of the central nervous system	OPDIVO OPDIVO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100521-PIP01-22-M01 (update)	Evinacumab	Treatment of elevated cholesterol	Evkeeza Evkeeza Evkeeza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100525-PIP01-22-M01 (update)	TILDRAKIZUMAB	Treatment of psoriasis	Ilumetri 100 mg solution for injection in pre-filled syringe Ilumetri 100 mg solution for injection in pre-filled syringe ILUMYA ILUMYA ILUMYA Ilumetri 100 mg solution for injection in pre-filled syringe Ilumetri	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100162-PIP01-21-M01 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100197-PIP01-21-M01 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	27/09/2022
MHRA-100158-PIP01-21-M01 (update)	PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Keytruda Keytruda	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100240-PIP01-21-M01 (update)	BOSUTINIB	Treatment of chronic myeloid leukaemia (CML)	Bosulif Bosulif	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100258-PIP01-21-M01 (update)	Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus	Not available yet	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100238-PIP01-21-M01 (update)	AVELUMAB	Treatment of malignant neoplasms of the CNS, lymphoid tissue and other malignant neoplasms.	Bavencio Bavencio Bavencio Bavencio Bavencio	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100260-PIP01-21-M01 (update)	CEMIPLIMAB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Libtayo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100182-PIP01-21-M01 (update)	Avalglucosidase alfa	Treatment of Pompe disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100233-PIP01-21-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cabometyx Cometriq Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Aptimetyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cometriq Cabometyx Cometriq Cabometyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100249-PIP01-21-M01 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma		Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100341-PIP01-21-M01 (update)	ISAVUCONAZONIUM SULFATE	Treatment of invasive aspergillosis Treatment of mucormycosis	Cresemba Cresemba Cresemba	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100328-PIP01-21-M01 (update)	METRELEPTIN	Treatment of lipodystrophy	Myalepta Powder for Solution for Injection Myalepta Myalepta	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022

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