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Displaying 201 - 220 of 478
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort descending
MHRA-100023-PIP01-21-M02 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100031-PIP01-21-M02 (update)
  • PALBOCICLIB
  • Treatment of Ewing sarcoma (EWS)
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • blisters in an outer carton/21 and 63 tablets
  • Ibrance
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100271-PIP01-21-M01 (update)
  • LINAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Trajenta
  • Trajenta
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 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-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-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-100695-PIP01-22-M02 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
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-100467-PIP01-22-M01 (update)
  • SEMAGLUTIDE
  • Treatment of obesity
  • Ozempic
  • Ozempic 0.25 mg, 0.5 mg, 1 mg
  • Endocrinology-Gynaecology-Fertility-metabolism
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-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-100025-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • Oncology
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-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-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