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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100083-PIP01-21-M01 (update)
  • Human Fibrinogen (INN) / Human Thrombin (INN)
  • HUMAN THROMBIN
  • HUMAN FIBRINOGEN
  • Treatment of: haemorrhage from a surgical procedure
  • CSF leakage from a neurosurgical procedure
  • EVICEL, Solution for sealant
  • EVARREST, Sealant matrix (withdrawn EU MAA)
  • EVICEL
  • EVICEL
  • EVICEL
  • Other: blood-derived topical haemostats
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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
MHRA-100055-PIP01-21
  • Edaravone
  • Treatment of Amyotrophic lateral sclerosis
  • Radicava
  • Radicut
  • Radicut
  • Radicut
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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