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PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100075-PIP01-21-M01 (update)	leniolisib	Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)	Joenja	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100075-PIP01-21-M02 (update)	leniolisib	Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)	Joenja Joenja Joenja Joenja	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100234-PIP01-21	(S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide	Treatment of dilated cardiomyopathy due to lamin A/C gene mutations		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		02/11/2022
MHRA-100355-PIP02-22	Fenebrutinib	Treatment of multiple sclerosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022
MHRA-100372-PIP01-21	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022
MHRA-100470-PIP01-22	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022
MHRA-100069-PIP01-21	RIBOCICLIB	Treatment of neuroblastoma	KISQALI KISQALI	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022
MHRA-100239-PIP01-21	multivalent pneumococcal polysaccharide conjugate vaccine	Prevention of disease caused by Streptococcus pneumoniae		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022
MHRA-100347-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory track disease caused by RSV via maternal immunisation.	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022
MHRA-100242-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory tract disease caused by respiratory syncytial virus.		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		07/12/2022
MHRA-100198-PIP01-21-M01 (update)	RURIOCTOCOG ALFA PEGOL	Treatment and prophylaxis of bleeding in patients with haemophilia A	Adynovi	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/11/2022
MHRA-100284-PIP01-21-M01 (update)	MEXILETINE HYDROCHLORIDE	Treatment of myotonic disorders		Other: Muscle disorders	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/11/2022
MHRA-100283-PIP01-21-M01 (update)	USTEKINUMAB	Treatment of Crohn's disease	Stelara Stelara Stelara Stelara Stelara Stelara Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/11/2022
MHRA-100286-PIP01-21-M01 (update)	USTEKINUMAB	Treatment of ulcerative colitis	Stelara Stelara Stelara Stelara Stelara Stelara Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/11/2022
MHRA-100283-PIP01-21-M02 (update)	USTEKINUMAB	Treatment of Crohn's disease	Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100321-PIP01-21-M01 (update)	GUSELKUMAB	Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/11/2022
MHRA-100511-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of Crohn's disease	TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
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-100779-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of chronic idiopathic arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100325-PIP01-21-M01 (update)	NALDEMEDINE	Treatment of opioid-induced constipation	Rizmoic Rizmoic SYMPROIC SYMPROIC	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/11/2022

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