EMEA-001404-PIP01-12 - paediatric investigation plan

Tetrabenazine (ADV6979)

Key facts

• Active Substance:
  Tetrabenazine (ADV6979)
• Therapeutic area:
  Neurology
• Decision number:
  P/0074/2015
• PIP number:
  EMEA-001404-PIP01-12
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of dystonia
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Advicenne Pharma

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/04/2015

Decision

P/0074/2015: EMA decision of 1 April 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for tetrabenazine (ADV6979) (EMEA-001404-PIP01-12)

AdoptedReference Number: EMA/138220/2015