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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-100224-PIP01-21	Etrasimod L-arginine	Treatment of ulcerative colitis	Not available at present	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100396-PIP01-21	sugemalimab	Treatment of non-small cell lung cancer (NSCLC)		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
MHRA-100293-PIP01-21	lenzilumab	Treatment of coronavirus disease 2019 (COVID-19)	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	29/07/2022
MHRA-100265-PIP01-21	BARICITINIB	Treatment of alopecia areata	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100199-PIP01-21	efgartigimod alfa	Treatment of Pemphigus		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
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-100109-PIP01-21	Islatravir	Prevention of human immunodeficiency virus (HIV-1) infection		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100100-PIP01-21	Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein	Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100062-PIP01-21	(14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate TEZACAFTOR DEUTIVACAFTOR	Treatment of Cystic Fibrosis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100091-PIP01-21	Rozanolixizumab	Treatment of Immune thrombocytopenia	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100027-PIP01-21	benzylamine derivative of benzofuran	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100301-PIP01-21	Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab )	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100309-PIP01-21	gantenerumab	Prevention of Alzheimer's disease	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100206-PIP01-21	EMPAGLIFLOZIN	Treatment of ischaemic heart disease	Jardiance Jardiance	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100194-PIP01-21	sivopixant	Treatment of unexplained or refractory chronic cough		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100204-PIP01-21	verdiperstat	Treatment of Amyotrophic lateral sclerosis	Dazluma	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100195-PIP01-21-M01 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/05/2022
MHRA-100184-PIP01-21	BENRALIZUMAB	Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100135-PIP01-21	anti-CD40L humanized monoclonal antibody (SAR441344)	Treatment of Sjogren's Syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100426-PIP01-22-M01 (update)	ligelizumab	Treatment of chronic spontaneous urticaria		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022

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