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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100695-PIP01-22-M04 (update)	Etranacogene dezaparvovec	Treatment of haemophilia B	Hemgenix Hemgenix Hemgenix Hemgenix	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101123-PIP01-23-M01 (update)	BREXUCABTAGENE AUTOLEUCEL	Treatment of acute lymphoblastic leukaemia	Brexucabtagene autoleucel Brexucabtagene autoleucel Brexucabtagene autoleucel	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100916-PIP01-23-M01 (update)	ELUXADOLINE	Treatment of diarrhoea irritable bowel syndrome.	Viberzi Viberzi Viberzi Viberzi Truberzi	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101027-PIP01-23-M01 (update)	ANIFROLUMAB	Treatment of Systemic Lupus Erythematosus	Saphnelo Saphnelo	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100718-PIP01-22-M02 (update)	deucravacitinib	Treatment of psoriasis	SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100203-PIP01-21-M02 (update)	Avacopan	Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis	Tavneos	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100105-PIP01-21-M01 (update)	ALPRAZOLAM	Treatment of epileptic seizures		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101141-PIP01-23-M01 (update)	mavacamten	Treatment of hypertrophic cardiomyopathy	CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101078-PIP01-23-M01 (update)	OLAPARIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).	Lynparza Lynparza Lynparza Lynparza Lynparza Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100099-PIP01-21-M04 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact (in Italy: Nubriveo)	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100586-PIP01-22-M02 (update)	DUPILUMAB	Treatment of asthma	Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	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-100037-PIP01-21-M02 (update)	ponesimod	Treatment of Multiple Sclerosis	Ponvory	Neurology Other: Autoimmune disease/dysfunction	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100485-PIP01-22-M02 (update)	AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide	Treatment of acute myeloid leukaemia	Tapotoclax	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100297-PIP01-21-M03 (update)	Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)	Treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100046-PIP01-21-M04 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri Ontozry	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
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-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-100468-PIP01-22-M02 (update)	EPTINEZUMAB	Prevention of migraine headaches	Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100462-PIP01-22-M02 (update)	FENFLURAMINE HYDROCHLORIDE	Treatment of Dravet Syndrome	Fintepla Fintepla Fintepla Fintepla Fintepla	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024

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