EMEA-001384-PIP02-17 - paediatric investigation plan

octenidine dihydrochloride

Key facts

• Active Substance:
  octenidine dihydrochloride
• Therapeutic area:
  • Infectious diseases
  • Other
• Decision number:
  P/0240/2018
• PIP number:
  EMEA-001384-PIP02-17
• Pharmaceutical form(s):
  Mouthwash
• Condition(s) / indication(s):
  Prevention of oral soft tissue infections
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Schülke & Mayr GmbH

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/08/2018

Decision

P/0240/2018: EMA decision of 15 August 2018 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for octenidine (dihydrochloride) (EMEA-001384-PIP02-17)

AdoptedReference Number: EMA/469733/2018