EMEA-001764-PIP03-15 - paediatric investigation plan

tetracaine hydrochloride

Oxymetazoline hydrochloride

Key facts

• Active substance:
  • tetracaine hydrochloride
  • Oxymetazoline hydrochloride
• Therapeutic area:
  Anaesthesiology
• Decision number:
  P/0082/2016
• PIP number:
  EMEA-001764-PIP03-15
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Local anaesthesia
• Route(s) of administration:
  Nasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/03/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-001764-PIP03-15
• Compliance opinion date:
  21/04/2017
• Compliance outcome:
  Positive

Decision

P/0082/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for tetracaine (hydrochloride) / oxymetazoline (hydrochloride) (EMEA-001764-PIP03-15)

Adopted Reference Number: EMA/131632/2016