EMEA-003117-PIP02-21 - paediatric investigation plan

Freeze-dried allergen extract of Betula pendula pollen

Key facts

• Active substance:
  Freeze-dried allergen extract of Betula pendula pollen
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0463/2022
• PIP number:
  EMEA-003117-PIP02-21
• Pharmaceutical form(s):
  Solution for skin-prick test
• Condition(s) / indication(s):
  Diagnosis of IgE mediated allergy to tree pollen of the birch group
• Route(s) of administration:
  Epicutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0463/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for freeze-dried allergen extract of Betula pendula pollen (EMEA-003117-PIP02-21)

Adopted Reference Number: EMA/790671/2022