EMA/PE/0000221424 - paediatric investigation plan

dermatophagoides pteronyssinus extract

Key facts

• Active substance:
  dermatophagoides pteronyssinus extract
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000221424
• PIP number:
  EMA/PE/0000221424
• Pharmaceutical form(s):
  Solution for skin-prick test
• Condition(s) / indication(s):
  Diagnosis of house dust mite allergy
• Route(s) of administration:
  Intraepidermal use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000221424 : EMA decision of 6 December 2024 on the refusal of a paediatric investigation plan and on the granting of a product-specific waiver for dermatophagoides pteronyssinus extract

Adopted Reference Number: EMADOC-1700519818-1793274