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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
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-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-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-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-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
MHRA-101008-PIP01-23-M01 (update)	AMBRISENTAN	Pulmonary Arterial Hypertension	Volibris Volibris	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100300-PIP01-21-M03 (update)	DARUNAVIR COBICISTAT	Treatment of human immunodeficiency virus (HIV-1) infection		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100301-PIP05-23	Nipocalimab	Treatment of Idiopathic inflammatory myopathies		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-101118-PIP01-23	5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7	Treatment of head and neck squamous cell carcinoma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101115-PIP01-23	Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)	Treatment of Amyotrophic lateral sclerosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100797-PIP01-22	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)	Prevention of influenza disease	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100789-PIP01-22	Fazirsiran	Treatment of congenital alpha-1 antitrypsin deficiency	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100562-PIP01-22	strontium-82 chloride/ rubidium-82 chloride	Visualisation of myocardial perfusion for diagnostic purposes	Ruby-Fill Ruby-Fill Ruby-Fill	Cardiovascular Diseases Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100971-PIP01-23	Sipavibart (AZD3152)	Prevention of coronavirus disease 2019 (COVID-19)		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100689-PIP01-22	Dersimelagon	Treatment of systemic sclerosis		Other: Autoimmune and immune dysfunction diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100680-PIP01-22	Influenza recombinant H7 haemagglutinin	Prevention of influenza infection		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100103-PIP01-21	Rozanolixizumab	Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease	Not available at present	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100594-PIP01-22	N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide	Treatment of focal onset seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024

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