EMEA-001258-PIP01-11-M08 - paediatric investigation plan

Dermatophagoides pteronyssinus

Dermatophagoides farinae

Key facts

• Active substance:
  • Dermatophagoides pteronyssinus
  • Dermatophagoides farinae
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0297/2022
• PIP number:
  EMEA-001258-PIP01-11-M08
• Pharmaceutical form(s):
  Oral lyophilisate
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of asthma
• Route(s) of administration:
  Sublingual use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/04/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001258-PIP01-11-M08
• Compliance opinion date:
  15/12/2023
• Compliance outcome:
  Positive

Decision

P/0297/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus / dermatophagoides farinae (Acarizax and associated names)

Adopted Reference Number: P/0297/2022