EMEA-000837-PIP01-10-M02 - paediatric investigation plan

aluminium hydroxide adsorbed

depigmented glutaraldehyde polymerised

birch pollen

Key facts

• Active substance:
  • aluminium hydroxide adsorbed
  • depigmented glutaraldehyde polymerised
  • birch pollen
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0527/2022
• PIP number:
  EMEA-000837-PIP01-10-M02
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of rhino-conjuctivitis
• 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:
  30/12/2022
• Compliance check done:
  No

Decision

P/0527/2022: EMA decision of 30 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of birch pollen (EMEA-000837- PIP01-10-M02

Adopted Reference Number: EMA/929767/2022