EMEA-000877-PIP03-17-M05 - paediatric investigation plan

bupivacaine

Key facts

• Invented name:
  Exparel liposomal
• Active substance:
  bupivacaine
• Therapeutic area:
  Pain
• Decision number:
  P/0021/2024
• PIP number:
  EMEA-000877-PIP03-17-M05
• Pharmaceutical form(s):
  • Prolonged-release dispersion for injection
  • Dispersion 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:
  09/02/2024
• Compliance check done:
  No

Decision

P/0021/2024 : EMA decision of 9 February 2024 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine (Exparel), (EMEA-000877-PIP03-17-M05)

Adopted Reference Number: EMA/27567/2024