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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-100164-PIP01-21	(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	18/03/2022
MHRA-100163-PIP01-21	Vupanorsen (PF-07285557)	Treatment of Hypertriglyceridemia Prevention of cardiovascular events	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100155-PIP01-21	efgartigimod alfa	Treatment of Chronic Inflammatory Demyelinating Polyneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100107-PIP01-21	1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate	Treatment of polycythaemia vera		Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100112-PIP01-21	savolitinib	Treatment of renal neoplasms	Not available	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100054-PIP01-21	RO7496998 (AT-527)	Treatment of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases Other: Pandemic	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	18/03/2022
MHRA-100060-PIP01-21	2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA	Treatment of Duchenne muscular dystrophy		Other: Neuromuscular	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
MHRA-100068-PIP01-21	VEDOLIZUMAB	Treatment of Pouchitis	Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio; Kynteles Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Kynteles Entyvio Entyvio Entyvio Entyvio	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	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-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-100048-PIP01-21	Afamitresgene autoleucel	Treatment of soft tissue sarcoma	Not available at present.	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
MHRA-100043-PIP01-21	zilucoplan	Treatment of myasthenia gravis	Zilbrysq Zilqivik	Neurology Other: Neurodegenerative disorder, auto-immune disease/dysfunction	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
MHRA-100044-PIP01-21	seltorexant	Treatment of major depressive disorder (MDD)	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
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
MHRA-100142-PIP01-21	Synthetic Hypericin	Treatment of cutaneous T-cell lymphoma	HyBryte	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100131-PIP01-21	ATEZOLIZUMAB	Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)	Tecentriq Tecentriq Tecentriq Tecentriq	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100111-PIP01-21	DORAVIRINE Islatravir	Treatment of human immunodeficiency virus-1 (HIV-1) infection.		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/12/2021
MHRA-100081-PIP01-21	Zibotentan DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE	Treatment of Chronic Kidney Disease	Not available at present	Other: Renal Disease	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
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-100152-PIP01-21	cosibelimab	Treatment of cutaneous squamous cell carcinoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/12/2021

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