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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100300-PIP01-21-M01 (update)	DARUNAVIR COBICISTAT	Treatment of HIV-1 Infection	REZOLSTA REZOLSTA REZOLSTA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
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-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-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-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-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-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-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-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-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-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-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-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-100075-PIP01-21	leniolisib	Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)	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	02/11/2022
MHRA-100019-PIP01-21	2-(3-(4-(1H-INDAZOL-5-YLAMINO)QUINAZOLIN-2-YL)PHENOXY)-N-ISOPROPYLACETAMIDE-METHANE SULFONIC ACID SALT	Treatment of chronic Graft versus Host Disease (cGVHD)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/10/2022
MHRA-100177-PIP01-21-M01 (update)	INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN	Prevention of influenza	FLUCELVAX TETRA FLUCELVAX TETRA FLUCELVAX QUADRIVALENT FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	21/10/2022
MHRA-100243-PIP01-21	DAPAGLIFLOZIN 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)	Prevention of cardiovascular events in patients with chronic heart failure		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	21/10/2022
MHRA-100035-PIP01-21	POVIDONE-IODINE ISOPROPYL ALCOHOL	Prevention of infection prior to invasive procedures	PurPrep	Other: Antiseptic	W: decision granting a waiver in all age groups for the listed condition(s).	No	21/10/2022
MHRA-100431-PIP01-22	derivative of pyrrolopyrimidine	Prevention of cardiovascular events in patients with heart failure		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100185-PIP01-21	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of cold agglutinin disease		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022

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