EMEA-000888-PIP01-10 - paediatric investigation plan

Betula alba

Betula pendula

Betula verrucosa

Key facts

• Active substance:
  • Betula alba
  • Betula pendula
  • Betula verrucosa
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/271/2010
• PIP number:
  EMEA-000888-PIP01-10
• Pharmaceutical form(s):
  Oromucosal solution
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of rhino-conjuctivitis
• Route(s) of administration:
  Sublingual use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/12/2010
• Compliance check done:
  No

Decision

P/271/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for allergens of birch pollen (betula alba / pendula / ve...

Adopted Reference Number: EMA/683356/2010