Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Xolair 75 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled syringe (injection). Clear to slightly opalescent, colourless to pale brownish-yellow solution. |
Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab*.
* Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Omalizumab |
Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab binds to IgE and prevents binding of IgE to FcεRI (high-affinity IgE receptor) on basophils and mast cells, thereby reducing the amount of free IgE that is available to trigger the allergic cascade. Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FcεRI receptors on basophils. |
| List of Excipients |
|---|
|
L-arginine hydrochloride |
0.5 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper and needle cap.
Pack containing 1 pre-filled syringe, and multipacks containing 4 (4 × 1) or 10 (10 × 1) pre-filled syringes.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/05/319/005
EU/1/05/319/006
EU/1/05/319/007
Date of first authorisation: 25 October 2005
Date of latest renewal: 22 June 2015
| Drug | Countries | |
|---|---|---|
| XOLAIR | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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