EMEA-000014-PIP01-07-M06 - paediatric investigation plan

paliperidone

paliperidone palmitate

Key facts

• Invented name:
  • Invega
  • Invega
• Active Substance:
  • paliperidone
  • paliperidone palmitate
• Therapeutic area:
  Psychiatry
• Decision number:
  P/154/2011
• PIP number:
  EMEA-000014-PIP01-07-M06
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Suspension for injection
• Condition(s) / indication(s):
  • Schizoaffective disorder
  • Schizophrenia
• Route(s) of administration:
  • Oral use
  • Intramuscular use
• Contact for public enquiries:

  Janssen-Cilag International NV

  [e-mail]; Belgium; Phone: [phone]; Fax: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/07/2011
• Compliance procedure number:
  EMEA-C-000014-PIP01-07-M06
• Compliance opinion date:
  14/02/2013
• Compliance outcome:
  Positive

Decision

P/154/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for paliperidone / paliperidone palmitate (Invega) ( EMEA-000014-PIP01-07-M06)

AdoptedReference Number: EMA/417965/2011