EMEA-000735-PIP01-09 - paediatric investigation plan

omalizumab

Key facts

• Invented name:
  • Xolair
  • Xolair
• Active Substance:
  omalizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/133/2010
• PIP number:
  EMEA-000735-PIP01-09
• Pharmaceutical form(s):
  • Powder and solvent for solution for injection
  • Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  • Treatment of allergic asthma
  • Treatment of chronic idiopathic urticaria
  • Treatment of chronic spontaneous urticaria
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novartis Europharm Limited

  United Kingdom; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/07/2010

Decision

P/133/2010: European Medicines Agency decision of 28 July 2010 on the refusal of a paediatric investigation plan and on the granting of a waiver for omalizumab, (Xolair) (EMEA-000735-PIP01-09) in accordance with Regulat...

AdoptedReference Number: EMA/463568/2010