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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-101016-PIP01-23	ublituximab	Treatment of multiple sclerosis	Briumvi Briumvi	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	20/12/2023
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
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-100056-PIP01-21	BENRALIZUMAB	Eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE)	FASENRA FASENRA FASENRA	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
MHRA-100057-PIP01-21	BENRALIZUMAB	Treatment of eosinophilic oesophagitis	FASENRA FASENRA FASENRA FASENRA	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
MHRA-100208-PIP01-21	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of non-alcoholic steatohepatitis		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100275-PIP01-21	SEMAGLUTIDE	Treatment of non-alcoholic steatohepatitis (NASH)	Ozempic OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Ozempic Ozempic Ozempic Ozempic OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100165-PIP01-21	PF-06865571	Treatment of non-alcoholic steatohepatitis	PF-06865571	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
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-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-100224-PIP02-22	Etrasimod L-arginine	Treatment of Crohn’s 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-100809-PIP01-22	Efruxifermin	Treatment of non-alcoholic steatohepatitis (NASH)	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
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-100332-PIP01-21	sotatercept	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	27/09/2022
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-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-100424-PIP01-22	zilebesiran sodium	Treatment of hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100558-PIP01-22	milvexian	Prevention of thromboembolism in patients with cardiovascular disease	Not available at present	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100270-PIP01-21	crinecerfont	Treatment of congenital adrenal hyperplasia		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100178-PIP01-21	DTX401 (a nonreplicating, recombinant adeno-associated virus serotype 8 vector that contains a codon-optimized, wild-type human glucose-6-phosphatase (G6PC) gene)	Treatment of glycogen storage disease type 1a (GSDIa)	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022

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