EMEA-002246-PIP01-17-M05 - paediatric investigation plan

bupivacaine

meloxicam

Key facts

• Active substance:
  • bupivacaine
  • meloxicam
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0296/2024
• PIP number:
  EMEA-002246-PIP01-17-M05
• Pharmaceutical form(s):
  Prolonged-release wound solution
• Condition(s) / indication(s):
  Treatment of acute postoperative pain
• Route(s) of administration:
  Intralesional use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0296/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine / meloxicam, (EMEA-002246-PIP01-17-M05)

Adopted Reference Number: EMA/364197/2024