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Displaying 421 - 426 of 426
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100067-PIP01-21-M01 (update)
  • nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100064-PIP01-21-M01 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 03/11/2021
MHRA-100065-PIP01-21-M01 (update)
  • TICAGRELOR
  • Prevention of thromboembolic events
  • Brilique
  • Brilique
  • Brilique
  • Brilique
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 03/11/2021
MHRA-100036-PIP01-21-M01 (update)
  • FERRIC MALTOL
  • Treatment of Iron deficiency anaemia (IDA)
  • FERACCRU
  • FERACCRU
  • ACCRUFER
  • FERACCRU
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100025-PIP01-21-M01 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100023-PIP01-21-M01 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021