Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of birch pollen - paediatric investigation plan

aluminium hydroxide adsorbed

depigmented glutaraldehyde polymerised

birch pollen

Key facts

• Active substance:
  • aluminium hydroxide adsorbed
  • depigmented glutaraldehyde polymerised
  • birch pollen
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/216/2009
• PIP number:
  Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of birch pollen
• Pharmaceutical form(s):
  Suspension for injection (multidose vial)
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of allergic rhinoconjunctivitis due to pollen
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  30/10/2009
• Compliance check done:
  No

Decision

P/216/2009: European Medicines Agency decision of 30 October 2009 on the refusal of a product specific waiver for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of birch pollen (EME...

Adopted Reference Number: EMEA/679780/2009