EMEA-003387-PIP01-22 - paediatric investigation plan

xylometazoline hydrochloride

sodium hyaluronate

Key facts

• Active substance:
  • xylometazoline hydrochloride
  • sodium hyaluronate
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0207/2023
• PIP number:
  EMEA-003387-PIP01-22
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of acute rhinosinusitis
• Route(s) of administration:
  Nasal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0207/2023 : EMA decision of 14 June 2023 on the refusal of a paediatric investigation plan and on the granting of a waiver for xylometazoline hydrochloride / sodium hyaluronate (EMEA-003387-PIP01-22)

Reference Number: EMA/253298/2023