EMEA-000789-PIP01-09 - paediatric investigation plan

aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and poa pratensis pollen (grasses-mix) and birch, alder and hazel pollen (tree-mix) (50/50)

Key facts

• Active substance:
  aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and poa pratensis pollen (grasses-mix) and birch, alder and hazel pollen (tree-mix) (50/50)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/245/2010
• PIP number:
  EMEA-000789-PIP01-09
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  • Treatment of rhino-conjuctivitis
  • Treatment of allergic rhinitis
• Route(s) of administration:
  Subcutaneous 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:
  No

Decision

P/245/2010: 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 aluminium hydroxide adsorbed, depigmented glutaraldeh...

Adopted Reference Number: EMA/672975/2010