EMEA-000582-PIP01-09-M03 - paediatric investigation plan

rupatadine fumarate

Key facts

• Invented name:
  Rupafin and associated names
• Active substance:
  rupatadine fumarate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0043/2014
• PIP number:
  EMEA-000582-PIP01-09-M03
• Pharmaceutical form(s):
  • Tablet
  • Granules
  • Oral liquid
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of chronic idiopathic urticaria
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  26/02/2014
• Compliance check done:
  Tak
• Compliance procedure number:
  EMEA-C-000582-PIP01-09-M03
• Compliance opinion date:
  21/03/2014
• Compliance outcome:
  Positive

Decision

P/0043/2014: European Medicines Agency decision of 26 February 2014 on the acceptance of a modification of an agreed paediatric investigation plan for rupadatine fumarate (Rupafin and associated names) (EMEA-000582-PIP0...

Adopted Reference Number: EMA/87776/2014