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Displaying 101 - 120 of 173

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100106-PIP01-21	3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxaminde sodium chloride solution 4.2% (w/v)	Treatment of primary ciliary dyskinesia		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/05/2022
MHRA-100230-PIP01-21	Thienopyrimidine Derivative	Treatment of fibrosing interstitial lung disease		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/05/2022
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-100305-PIP01-21	Single chain urokinase plasminogen activator (scuPA)	Treatment of pleural effusion		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100315-PIP01-21	Brensocatib	Treatment of non‐cystic fibrosis bronchiectasis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100141-PIP01-21	BENRALIZUMAB	Treatment of Eosinophilic Granulomatosis with Polyangitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN	Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100894-PIP01-23	depemokimab	Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100339-PIP01-21	Autologous selected renal cells	Treatment of Chronic Kidney Disease	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		04/05/2022
MHRA-100403-PIP01-21	Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)	Treatment of focal segmental glomerulosclerosis	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		07/12/2022
MHRA-100273-PIP01-21	5-Ethoxy-1-(6-(3-methyl-2-((5-methyl-2-(tetrahydro-2Hpyran- 4-yl)-1,2,3,4-tetrahydroisoquinolin-6- yl)methoxy)phenyl)pyridin-2-yl)-1H-pyrazole-4- carboxylic acid	Treatment of Chronic Kidney Disease		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		07/12/2022
MHRA-100628-PIP01-22	Sibeprenlimab	Treatment of primary immunoglobulin A nephropathy		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100605-PIP01-22	sparsentan	Treatment of immunoglobulin A nephropathy	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100606-PIP01-22	sparsentan	Treatment of focal segmental glomerulosclerosis	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100446-PIP01-22	Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one	Treatment of Chronic Kidney Disease		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100878-PIP01-23	vibegron	Treatment of myoneurogenic bladder disorders		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100872-PIP01-23	pudexacianinium chloride	Visualisation of ureter		Uro-Nephrology Gastroenterology-Hepatology Diagnostic Endocrinology-Gynaecology-Fertility-metabolism Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/01/2024
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-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-100105-PIP01-21	ALPRAZOLAM	Treatment of epileptic seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100151-PIP01-21	CANNABIDIOL	Treatment of epilepsy with myoclonic-atonic seizures (EMAS)	Epidyolex Epidyolex Epidyolex Epidiolex Epidyolex Epidyolex Epidiolex	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022

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