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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort ascending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100775-PIP01-22-M01 (update)	(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4- hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride Maralixibat chloride	Treatment of Alagille Syndrome (ALGS)	maralixibat chloride	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	01/08/2023
MHRA-100775-PIP01-22-M02 (update)	(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride Maralixibat chloride	Treatment of Alagille Syndrome (ALGS)	Livmarli (maralixibat chloride) LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	01/08/2023
MHRA-100778-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of ulcerative colitis	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		24/08/2023
MHRA-100786-PIP01-22-M01 (update)	TOFACITINIB CITRATE	Treatment of ulcerative colitis	XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		24/08/2023
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-100137-PIP01-21-M02 (update)	linaclotide	Treatment of functional constipation	Constella Constella Constella Constella Constella	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100931-PIP01-23-M01 (update)	mirikizumab	Treatment of ulcerative colitis Treatment of Crohn's disease		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100625-PIP01-22-M01 (update)	RISANKIZUMAB	Treatment of psoriasis	Skyrizi Skyrizi Skyrizi Skyrizi	Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100991-PIP01-23	Maralixibat chloride	Treatment of progressive familial intrahepatic cholestasis (PFIC)	LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/01/2024
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-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-100089-PIP01-21-M02 (update)	DUPILUMAB	Treatment of eosinophilic oesophagitis	Dupixent Dupixent	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-101304-PIP01-23-M01 (update)	FILGOTINIB MALEATE	Treatment of ulcerative colitis	Jyseleca Jyseleca Jyseleca Jyseleca Jyseleca	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		01/05/2024
MHRA-100066-PIP01-21	efgartigimod alfa	Treatment of myastenia gravis (MG)		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		03/11/2021
MHRA-100055-PIP01-21	Edaravone	Treatment of Amyotrophic lateral sclerosis	Radicava Radicut Radicut Radicut	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/11/2021
MHRA-100046-PIP01-21-M01 (update)	cenobamate	Treatment of epilepsy	ONTORZY Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	03/11/2021
MHRA-100074-PIP01-21	GABAPENTIN	Treatment of Postherpetic Neuralgia	Gralise	Neurology Pain	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/12/2021
MHRA-100097-PIP01-21-M01 (update)	eladocagene exuparvovec	Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency	Upstaza	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100098-PIP01-21-M01 (update)	ATALUREN	Treatment of dystrophinopathy	Translarna Translarna Translarna Translarna Translarna Translarna Translarna Translarna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100080-PIP01-21	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of Immune Thrombocytopenic Purpura		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/12/2021

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