EMA/PE/0000242278 - paediatric investigation plan

betula pollen extract

Key facts

• Active substance:
  betula pollen extract
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  EMA/PE/0000242278
• PIP number:
  EMA/PE/0000242278
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/05/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000242278 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for betula pollen extract

Adopted Reference Number: EMADOC-1700519818-2115307