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Displaying 101 - 120 of 162
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
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-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
MHRA-100382-PIP01-21
  • RAVULIZUMAB
  • Treatment of myasthenia gravis
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
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-100574-PIP01-22
  • lixmabegagene relduparvovec
  • Treatment of GM1 gangliosidosis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100482-PIP01-22
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of Niemann-Pick Disease type C (NPC)
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100126-PIP01-21-M01 (update)
  • Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene
  • Duchenne Muscular Dystrophy
  • fordadistrogene movaparvovec
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/06/2023
MHRA-100118-PIP02-22
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100299-PIP01-21
  • Humanized monoclonal IgG1-based antibody
  • Treatment of spinal muscular atrophy
  • Not available at present
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023