EMEA-001015-PIP01-10 - paediatric investigation plan

Dermatophagoides pteronyssinus

Dermatophagoides farinae

Key facts

• Active substance:
  • Dermatophagoides pteronyssinus
  • Dermatophagoides farinae
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/146/2011
• PIP number:
  EMEA-001015-PIP01-10
• Pharmaceutical form(s):
  Oromucosal drops
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Sublingual use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/06/2011
• Compliance check done:
  No

Decision

P/146/2011: EMA decision of 9 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chemically modified house dust mites allergen extract

Adopted Reference Number: EMA/417760/2011

Chemically modified house dust mites allergen extract (dermatophagoides pteronyssinus and dermatophagoides farinae) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision