EMEA-000902-PIP01-10-M01 - paediatric investigation plan

Dermatophagoides pteronyssinus

Dermatophagoides farinae

Key facts

• Active substance:
  • Dermatophagoides pteronyssinus
  • Dermatophagoides farinae
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0211/2023
• PIP number:
  EMEA-000902-PIP01-10-M01
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0211/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed PIP for adsorbed modified allergen extract of a mixture of 50% dermatophagoides pteronyssinus and 50% dermatophagoides farinae (EMEA-000902-PIP01-10-M01)

Reference Number: EMA/236232/2023