EMEA-000923-PIP02-10 - paediatric investigation plan

mixture of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis (Grasses-Mix) and Secale cereale (75/25) allergen extracts

Key facts

• Active substance:
  mixture of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis (Grasses-Mix) and Secale cereale (75/25) allergen extracts
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/263/2010
• PIP number:
  EMEA-000923-PIP02-10
• Pharmaceutical form(s):
  Oromucosal solution
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of rhino-conjuctivitis
• 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:
  26/11/2010
• Compliance check done:
  Nee

Decision

P/263/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mixture of Phleum pratense, Dactylis glomerata, Festu...

Adopted Reference Number: EMA/710530/2010