EMEA-000548-PIP01-09-M08 - paediatric investigation plan

beclometasone dipropionate

formoterol fumarate dihydrate

Key facts

• Invented name:
  • Foster and associated names
  • Kantos and associated names
  • Kantos Master and associated names
  • Inuvair and associated names
• Active substance:
  • beclometasone dipropionate
  • formoterol fumarate dihydrate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0159/2018
• PIP number:
  EMEA-000548-PIP01-09-M08
• Pharmaceutical form(s):
  • Inhalation powder
  • Pressurised inhalation (solution)
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/06/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000548-PIP01-09-M08
• Compliance opinion date:
  26/04/2019
• Compliance outcome:
  Positive

Decision

P/0159/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for beclometasone (dipropionate)/formoterol (fumarate dihydrate) (Foster and associated names, Kantos and associated names, Inuvair..

Adopted Reference Number: EMA/324470/2018