EMEA-003413-PIP01-23 - paediatric investigation plan

povidone

iodine

Key facts

• Active substance:
  • povidone
  • iodine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0273/2023
• PIP number:
  EMEA-003413-PIP01-23
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of acute nasopharyngitis (common cold)
• Route(s) of administration:
  Nasal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0273/2023 : EMA decision of 14 July 2023 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for povidone-iodine, (EMEA-003413-PIP01-23)

Reference Number: EMA/251132/2023