EMEA-002246-PIP01-17-M03 - paediatric investigation plan

bupivacaine

meloxicam (HTX-011)

Key facts

• Invented name:
  Zynrelef
• Active Substance:
  • bupivacaine
  • meloxicam (HTX-011)
• Therapeutic area:
  Pain
• Decision number:
  P/0160/2023
• PIP number:
  EMEA-002246-PIP01-17-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of acute postoperative pain
• Route(s) of administration:
  • Application to surgical site
  • Intralesional use
• Contact for public enquiries:

  Heron Therapeutics B.V.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/05/2023

Decision

P/0160/2023: Decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine / meloxicam (Zynrelef), (EMEA-002246-PIP01-17-M03)

Reference Number: EMA/170272/2023