Displaying 201 - 220 of 773
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
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-100374-PIP01-21
  • Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene
  • Treatment of frontotemporal dementia
  • Neurology
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
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-100445-PIP01-22
  • RAVULIZUMAB
  • Treatment of Neuromyelitis Optica Spectrum Disorder
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 07/12/2022
MHRA-100441-PIP01-22-M01 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne Muscular Dystrophy (DMD)
  • Elevidys
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100476-PIP01-22
  • Anti-(alpha-synuclein) human monoclonal antibody
  • Treatment of Multiple System Atrophy
  • Treatment of Parkinson's Disease
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100135-PIP02-22
  • anti-CD40L humanised monoclonal antibody (SAR441344)
  • Treatment of progressive Multiple Sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100556-PIP01-22
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
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-100087-PIP01-21-M02 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100118-PIP01-21-M02 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100289-PIP01-21-M02 (update)
  • GALCANEZUMAB
  • Prevention of migraine headache
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100462-PIP01-22-M01 (update)
  • FENFLURAMINE HYDROCHLORIDE
  • Treatment of Dravet syndrome
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100468-PIP01-22-M01 (update)
  • EPTINEZUMAB
  • Prevention of migraine headaches
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100743-PIP01-22-M01 (update)
  • efgartigimod alfa
  • Treatment of generalised myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 02/02/2023
MHRA-100316-PIP02-22
  • latozinemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100610-PIP01-22-M01 (update)
  • ECULIZUMAB
  • Treatment of myasthenia gravis
  • SOLIRIS
  • SOLIRIS
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100547-PIP01-22-M01 (update)
  • PEGINTERFERON BETA-1A
  • Treatment of multiple sclerosis
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023