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Displaying 121 - 140 of 478
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
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-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-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-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-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
MHRA-100815-PIP01-22-M01 (update)
  • SIPONIMOD
  • Treatment of Multiple Sclerosis
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100817-PIP01-22-M01 (update)
  • SIPONIMOD
  • Treatment of Multiple Sclerosis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023