EMEA-000439-PIP02-11 - paediatric investigation plan

Bitopertin

Key facts

• Active Substance:
  Bitopertin
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0229/2012
• PIP number:
  EMEA-000439-PIP02-11
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Roche Registration Limited

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/10/2012

Decision

P/0229/2012: EMA decision of 4 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bitopertin (EMEA-000439-PIP02-11)

AdoptedReference Number: EMA/587320/2012