EMEA-000836-PIP01-10-M01 - paediatric investigation plan

Dermatophagoides pteronyssinus

Dermatophagoides farinae

Key facts

• Active substance:
  • Dermatophagoides pteronyssinus
  • Dermatophagoides farinae
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0248/2024
• PIP number:
  EMEA-000836-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:
  18/07/2024
• Compliance check done:
  No

Decision

P/0248/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus / dermatophagoides farinae extracts (50%/50%), (EMEA-000836-PIP01-10-M01)

Adopted Reference Number: EMA/319197/2024