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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101073-PIP01-23-M01 (update)
  • MIRABEGRON
  • Treatment of idiopathic overactive bladder
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
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-100123-PIP01-21-M02 (update)
  • SARILUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Kevzara
  • Kevzara
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/01/2024
MHRA-101131-PIP01-23-M01 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCTYO
  • BLINCYTO
  • BLINCYTO
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  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100840-PIP01-23-M01 (update)
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101053-PIP01-23-M01 (update)
  • DOLUTEGRAVIR
  • ABACAVIR
  • LAMIVUDINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • TRIUMEQ
  • TRIUMEQ
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100544-PIP01-22-M02 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101030-PIP01-23
  • Inhibitor of receptor-interacting serine/threonine-protein kinase 1 (RIPK1) (SAR443820)
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100858-PIP01-23
  • sabatolimab
  • Treatment of myelodysplastic syndromes
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100978-PIP01-23
  • Genetically detoxified Pertussis Toxin (PTgen) and Pertussis Filamentous Haemagglutinin (FHA)
  • Prevention of Pertussis disease
  • Pertagen
  • Pertagen
  • Pertagen
  • Pertagen aPgen
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-101034-PIP01-23
  • Belrestotug
  • GSK4428859A
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-101003-PIP01-23-M01 (update)
  • garadacimab
  • Prevention of hereditary angioedema
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 06/03/2024
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