EMA/PE/0000235857 - paediatric investigation plan

bupivacaine

Key facts

• Invented name:
  Exparel liposomal
• Active substance:
  bupivacaine
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  P/0021/2024
• PIP number:
  EMA/PE/0000235857
• Pharmaceutical form(s):
  • Prolonged-release dispersion for injection
  • Dispersion for injection
  • Suspension for injection
• Condition(s) / indication(s):
  Postsurgical analgesia
• Route(s) of administration:
  • Perineural use
  • Infiltration use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/04/2025
• Compliance check done:
  Não

Decision

EMA/PE/0000235857: EMA decision of 15 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine (Exparel)

Adopted Reference Number: EMADOC-1700519818-2039838