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Displaying 321 - 340 of 478
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100369-PIP01-21-M01 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold
  • Galafold
  • Galafold 123 mg capsules
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100369-PIP01-21-M02 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold 123 mg capsules
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100442-PIP01-22-M01 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100442-PIP01-22-M02 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/04/2024
MHRA-100169-PIP01-21-M01 (update)
  • BETIBEGLOGENE AUTOTEMCEL
  • Treatment of beta-thalassaemia
  • zynteglo
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100225-PIP01-21-M01 (update)
  • recombinant parathyroid hormone
  • Treatment of hypoparathyroidism
  • Natpar
  • Natpar
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100440-PIP01-22-M01 (update)
  • BICTEGRAVIR
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of Human immunodeficiency virus (HIV-1) infection
  • Biktarvy
  • Infectious diseases
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-100462-PIP01-22-M02 (update)
  • FENFLURAMINE HYDROCHLORIDE
  • Treatment of Dravet Syndrome
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
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-100468-PIP01-22-M02 (update)
  • EPTINEZUMAB
  • Prevention of migraine headaches
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • 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 30/04/2024
MHRA-100405-PIP01-21-M01 (update)
  • LIRAGLUTIDE
  • Treatment of obesity
  • Saxenda
  • Saxenda
  • Saxenda
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100499-PIP01-22-M01 (update)
  • Giroctocogene Fitelparvovec
  • Treatment of haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100451-PIP01-22-M01 (update)
  • fidanacogene elaparvovec
  • Treatment of congenital factor IX deficiency (haemophilia B)
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100451-PIP01-22-M02 (update)
  • fidanacogene elaparvovec
  • Treatment of congenital factor IX deficiency (haemophilia B)
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100606-PIP01-22-M01 (update)
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Filspari
  • Filspari
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100811-PIP01-22
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • Other: Neuromuscular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100811-PIP01-22-M01 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100811-PIP01-22-M02 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100274-PIP01-21-M02 (update)
  • ELIGLUSTAT
  • Treatment of Gaucher Disease Type 2
  • Treatment of Gaucher Disease Type 1 and Type 3
  • CERDELGA
  • Other: Lysosomal Storage Disorder
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023