EMEA-001742-PIP02-16 - paediatric investigation plan

Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one

Key facts

• Active Substance:
  Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0338/2016
• PIP number:
  EMEA-001742-PIP02-16
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of psychosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Boehringer Ingelheim International GmbH

  Tel. [phone]; Email: [e-mail]

• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  02/12/2016

Decision

P/0338/2016: EMA decision of 2 December 2016 on the refusal of a paediatric investigation plan and on the refusal of a waiver for derivative of 4Hpyrazolo[ 3,4-d]pyrimidin-4-one (EMEA-001742-PIP02-16)

AdoptedReference Number: EMA/757989/2016