EMEA-000735-PIP01-09

Key facts

Invented name
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 syringes
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: paediatric.enquiries@novartis.com
Tel. +41 6132 41111
Fax +41 6132 48001
Decision type
W: decision granting a waiver in all age groups for all conditions/indications

Decision

How useful was this page?

Add your rating