EMEA-001506-PIP02-14-M01 - paediatric investigation plan

Basmisanil

Key facts

• Active Substance:
  Basmisanil
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0052/2016
• PIP number:
  EMEA-001506-PIP02-14-M01
• Pharmaceutical form(s):
  Granules
• Condition(s) / indication(s):
  Treatment of down syndrome
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Roche Registration Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/03/2016

Decision

P/0052/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for basmisanil (EMEA-001506-PIP02-14-M01)

AdoptedReference Number: EMA/133060/2016