Displaying 161 - 180 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
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-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-100118-PIP01-21-M01 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. 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-100087-PIP01-21-M01 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes
  • VIMPAT
  • lacosamide
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • lacosamide
  • lacosamide
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100099-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100099-PIP01-21-M02 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact (in Italy: Nubriveo)
  • Briviact
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100099-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100108-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of epilepsy with partial onset seizures.
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • BRIVLERA
  • BRIVLERA
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100248-PIP01-21-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100342-PIP01-21-M01 (update)
  • arimoclomol citrate
  • Treatment of Niemann-Pick Disease, type C
  • MIPLYFFA
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
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-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-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-100316-PIP01-21
  • latozinemab
  • Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100037-PIP01-21-M01 (update)
  • ponesimod
  • Treatment of Multiple Sclerosis
  • Ponvory
  • Neurology
  • Other: Autoimmune disease/disfunction
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100046-PIP01-21-M02 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Xcopri
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100289-PIP01-21-M01 (update)
  • GALCANEZUMAB
  • Prevention of migraine headaches
  • Emgality
  • Emgality
  • Emgality
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100336-PIP01-21-M01 (update)
  • soticlestat
  • Treatment of Dravet Syndrome
  • Lennox-Gastaut Syndrome
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
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