EMEA-000990-PIP02-10 - paediatric investigation plan

azelastine (hydrochloride)

fluticasone propionate

Key facts

• Active substance:
  • azelastine (hydrochloride)
  • fluticasone propionate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/82/2011
• PIP number:
  EMEA-000990-PIP02-10
• Pharmaceutical form(s):
  • Nasal spray
  • Suspension
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of rhino-conjuctivitis
• Route(s) of administration:
  Nasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/04/2011
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000990-PIP02-10
• Compliance opinion date:
  24/06/2011
• Compliance outcome:
  Positive

Decision

P/82/2011: EMA decision of 6 April 2011 on the agreement of a paediatric investigation plan and on the granting of a waiver for azelastine (hydrochloride) / fluticasone (propionate) (EMEA-000990-PIP02-10)

Adopted Reference Number: EMA/221225/2011