EMEA-000841-PIP01-10 - paediatric investigation plan

aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (50/50)

Key facts

• Active substance:
  aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (50/50)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/257/2010
• PIP number:
  EMEA-000841-PIP01-10
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of rhino-conjuctivitis
• 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/257/2010: EMA decision of 26 November 2010 on the agreement of a PIP and on the granting of a deferral and a waiver for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts of Phleum...

Adopted Reference Number: EMA/710437/2010