EMEA-002149-PIP01-17 - paediatric investigation plan

DaxibotulinumtoxinA

Key facts

• Active Substance:
  DaxibotulinumtoxinA
• Therapeutic area:
  Other
• Decision number:
  P/0220/2017
• PIP number:
  EMEA-002149-PIP01-17
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of glabellar lines
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Revance Therapeutics Inc

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2017

Decision

P/0220/2017: EMA decision of 9 August 2017 on the granting of a product specific waiver for daxibotulinumtoxinA (EMEA-002149-PIP01-17)

AdoptedReference Number: EMA/436417/2017