Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract of birch, alder and hazel pollen - paediatric investigation plan

aluminium hydroxide adsorbed

depigmented glutaraldehyde polymerised

birch pollen

alder pollen

hazel pollen

Key facts

• Active Substance:
  • aluminium hydroxide adsorbed
  • depigmented glutaraldehyde polymerised
  • birch pollen
  • alder pollen
  • hazel pollen
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/218/2009
• PIP number:
  Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract of birch, alder and hazel 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
• Contact for public enquiries:

  LETI Pharma GmbH

  E-mail: [e-mail]; Country: Germany; Phone: [phone]; Fax: [phone]

• 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

Decision

P/218/2009: European Medicines Agency decision of 30 October 2009 on the refusal of a product specific waiver for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract of birch, alder a...

AdoptedReference Number: EMEA/679781/2009