EMEA-000932-PIP01-10-M02 - paediatric investigation plan

modified allergen extract of birch pollen

Key facts

• Active substance:
  modified allergen extract of birch pollen
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0075/2022
• PIP number:
  EMEA-000932-PIP01-10-M02
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  11/03/2022
• Compliance check done:
  No

Decision

P/0075/2022 : EMA decision of 11 March 2022 on the refusal of a modification of an agreed paediatric investigation plan for modified allergen extract of birch pollen (EMEA-000932-PIP01-10-M02)

Adopted Reference Number: EMA/65170/2022