EMEA-000228-PIP01-08-M04 - paediatric investigation plan

asenapine maleate

Key facts

• Invented name:
  • Sycrest
  • Sycrest
• Active substance:
  asenapine maleate
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0299/2014
• PIP number:
  EMEA-000228-PIP01-08-M04
• Pharmaceutical form(s):
  Sublingual tablet
• Condition(s) / indication(s):
  Treatment of bipolar I disorder
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/11/2014
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-000228-PIP01-08-M04
• Compliance opinion date:
  18/08/2017
• Compliance outcome:
  Positive

Decision

P/0299/2014: EMA decision of 24 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for asenapine (maleate) (Sycrest) (EMEA-000228-PIP01-08-M04)

Adopted Reference Number: EMA/624761/2014