Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Xolair 75 mg solution for injection in pre-filled syringe.
Xolair 75 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). Clear to slightly opalescent, colourless to pale brownish-yellow solution. |
Xolair 75 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 75 mg of omalizumab* in 0.5 ml solution.
Xolair 75 mg solution for injection in pre-filled pen: Each pre-filled pen contains 75 mg of omalizumab* in 0.5 ml solution.
* Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology.
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) and lowers free IgE levels. The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine parent antibody that binds to IgE. |
| List of Excipients |
|---|
|
Arginine hydrochloride |
Xolair 75 mg solution for injection in pre-filled syringe is supplied as 0.5 ml solution in a pre-filled syringe barrel (type I glass) with 26-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.
Pack sizes: packs containing 1 pre-filled syringe, and multipacks containing 4 (4 × 1) or 10 (10 × 1) pre-filled syringes.
Xolair 75 mg solution for injection in pre-filled syringe is supplied as 0.5 ml solution in a pre-filled syringe barrel (type I glass) with 27-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.
Pack sizes: packs containing 1 pre-filled syringe, and multipacks containing 3 (3 × 1) or 6 (6 × 1) pre-filled syringes.
Xolair 75 mg solution for injection in pre-filled pen is supplied as 0.5 ml solution in a pre-filled pen barrel (type I glass) with 27-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.
Pack sizes: packs containing 1 pre-filled pen, and multipacks containing 3 (3 × 1) or 6 (6 × 1) pre-filled pens.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Xolair 75 mg solution for injection in pre-filled syringe:
EU/1/05/319/005
EU/1/05/319/006
EU/1/05/319/007
EU/1/05/319/018
EU/1/05/319/019
EU/1/05/319/020
Xolair 75 mg solution for injection in pre-filled pen:
EU/1/05/319/021
EU/1/05/319/022
EU/1/05/319/023
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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