EMEA-000235-PIP02-10-M02 - paediatric investigation plan

aripiprazole

Key facts

• Invented name:
  Abilify
• Active Substance:
  aripiprazole
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0256/2012
• PIP number:
  EMEA-000235-PIP02-10-M02
• Pharmaceutical form(s):
  • Tablet
  • Orodispersible tablet
  • Oral solution
  • Solution for injection
• Condition(s) / indication(s):
  • Treatment of bipolar affective disorder
  • Treatment of schizophrenia
• Route(s) of administration:
  • Oral use
  • Intramuscular use
• Contact for public enquiries:

  Otsuka Pharmaceutical Europe Ltd.

  E-mail: [e-mail]; Country: United Kingdom; Tel. [phone]; Fax [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  26/10/2012
• Compliance procedure number:
  EMEA-C-000235-PIP02-10-M02
• Compliance opinion date:
  24/06/2016
• Compliance outcome:
  Positive

Decision

P/0256/2012: EMA decision of 26 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aripiprazole (Abilify), (EMEA-000235-PIP02-10-M02)

AdoptedReference Number: EMA/646932/2012