EMEA-002170-PIP01-17 - paediatric investigation plan

tolonium chloride

Key facts

• Active substance:
  tolonium chloride
• Therapeutic area:
  Other
• Decision number:
  P/0370/2017
• PIP number:
  EMEA-002170-PIP01-17
• Pharmaceutical form(s):
  Oromucosal gel
• Condition(s) / indication(s):
  Treatment of dental and oral soft tissue infections
• Route(s) of administration:
  • Dental use
  • Oromucosal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2017
• Compliance check done:
  No

Decision

P/0370/2017: EMA decision of 1 December 2017 on the granting of a product specific waiver for tolonium chloride (EMEA-002170-PIP01-17)

Reference Number: EMA/704008/2017