EMA/PE/0000221803 - paediatric investigation plan

betula pendula pollen extract

Key facts

• Active substance:
  betula pendula pollen extract
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000221803
• PIP number:
  EMA/PE/0000221803
• Pharmaceutical form(s):
  Solution for skin-prick test
• Condition(s) / indication(s):
  Diagnosis of birch pollen allergy
• Route(s) of administration:
  Intraepidermal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000221803: EMA decision of 6 December 2024 on the refusal of a paediatric investigation plan and on the granting of a waiver for betula pendula pollen extract

Adopted Reference Number: EMADOC-1700519818-1793589