EMEA-001148-PIP01-11 - paediatric investigation plan

Dextromethorphan (hydrobromide)

quinidine sulfate

Key facts

• Active Substance:
  • Dextromethorphan (hydrobromide)
  • quinidine sulfate
• Therapeutic area:
  Neurology
• Decision number:
  P/240/2011
• PIP number:
  EMEA-001148-PIP01-11
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of pseudobulbar affect (uncontrollable laughing and/or crying)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Avanir Pharmaceuticals, Incorporated

  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:
  30/09/2011

Decision

P/240/2011: EMA decision of 30 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dextromethorphan (hydrobromide) / quinidine sulfate...

AdoptedReference Number: EMA/706711/2011