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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100628-PIP01-22	Sibeprenlimab	Treatment of primary immunoglobulin A nephropathy		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100439-PIP01-22	Asundexian	Prevention of arterial thromboembolism	Not available at present.	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100588-PIP01-22	UB-612	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present		P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100345-PIP01-21	Magrolimab	Treatment of myelodysplastic syndromes (including juvenile myelomonocytic leukaemia) Treatment of acute myeloid leukaemia		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100508-PIP01-22	tezepelumab	Treatment of chronic spontaneous urticaria	Not available at present TEZSPIRE	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100514-PIP01-22	Gliadin Protease	Treatment of coeliac disease		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100503-PIP01-22	efavaleukin alfa	Treatment of ulcerative colitis	Not available at present	Other: Inflammatory Bowel Disease	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100585-PIP01-22	Adintrevimab	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Bredaygio	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100209-PIP01-21	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of obesity		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100287-PIP01-21	SEMAGLUTIDE	Treatment of obesity	Not available at present Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100519-PIP01-22	RSV preF protein	Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)			P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100421-PIP01-22	efavaleukin alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100519-PIP01-22	RSV preF protein	Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)			P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100482-PIP01-22	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick Disease type C (NPC)		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100469-PIP01-22	delgocitinib	Treatment of chronic hand eczema	no invented name yet	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100574-PIP01-22	lixmabegagene relduparvovec	Treatment of GM1 gangliosidosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100317-PIP01-21	Ralinepag	Treatment of pulmonary arterial hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100432-PIP01-22	2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1- yl)phenyl)nicotinamide fumarate dihydrate	Treatment of fibrodysplasia ossificans progressiva		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100030-PIP01-21	9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa (ExPEC9V)	Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100273-PIP01-21	5-Ethoxy-1-(6-(3-methyl-2-((5-methyl-2-(tetrahydro-2Hpyran- 4-yl)-1,2,3,4-tetrahydroisoquinolin-6- yl)methoxy)phenyl)pyridin-2-yl)-1H-pyrazole-4- carboxylic acid	Treatment of Chronic Kidney Disease		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022

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