EMEA-000931-PIP01-10 - paediatric investigation plan

birch pollen

hazel pollen

Key facts

• Active Substance:
  • birch pollen
  • hazel pollen
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/309/2010
• PIP number:
  EMEA-000931-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
• Contact for public enquiries:

  ROXALL Medizin GmbH

  [e-mail]; Phone: [phone]; Fax: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/12/2010

Decision

P/309/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of birch and hazel pollen (...

AdoptedReference Number: EMA/769333/2010