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Displaying 481 - 500 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
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-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-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
MHRA-100599-PIP01-22
  • Flortaucipir F18
  • Diagnosis of Alzheimer's disease
  • Tauvid
  • Tauvid
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
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-100709-PIP01-22-M02 (update)
  • Rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100709-PIP01-22-M01 (update)
  • rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100699-PIP01-22-M01 (update)
  • DIROXIMEL FUMARATE
  • Treatment of Multiple Sclerosis
  • Vumerity
  • Vumerity
  • Vumerity
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100717-PIP01-22-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
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-100807-PIP01-22-M01 (update)
  • RIMEGEPANT SULFATE
  • Treatment of migraine headaches
  • Vydura
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100801-PIP01-22
  • eplontersen
  • Treatment of transthyretin-mediated amyloidosis
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(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