Lidocaine/tetracaine - paediatric investigation plan

lidocaine

tetracaine

Key facts

• Active substance:
  • lidocaine
  • tetracaine
• Therapeutic area:
  Anaesthesiology
• Decision number:
  P/125/2010
• PIP number:
  Lidocaine/tetracaine
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Local anaesthesia
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/07/2010
• Compliance check done:
  No

Decision

P/125/2010: European Medicines Agency decision of 28 July 2010 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for lidocaine/tetracaine (EMEA-000168-PIP...

Adopted Reference Number: EMA/464924/2010