EMEA-001034-PIP01-10 - paediatric investigation plan

Risperidone

Key facts

• Invented name:
  Risperdal and associated names
• Active Substance:
  Risperidone
• Therapeutic area:
  Psychiatry
• Decision number:
  P/167/2011
• PIP number:
  EMEA-001034-PIP01-10
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of conduct disorder
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Wockhardt UK Ltd

  [e-mail]; United Kingdom; Phone: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/07/2011

Decision

P/167/2011: EMA decision of 6 July 2011 on the agreement of a paediatric investigation plan and on the granting of a waiver for risperidone (Risperdal and associated names) (EMEA-001034-PIP01-10)

AdoptedReference Number: EMA/484972/2011