Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Extavia 250 microgram/ml powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. Powder – white to off-white in colour. Solvent – clear/colourless solution. |
Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial*.
After reconstitution, each ml contains 250 microgram (8.0 million IU) of recombinant interferon beta1b.
* produced by genetic engineering from strain of Escherichia coli.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Interferon beta-1b |
Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activity. The mechanisms by which interferon beta-1b exerts its actions in multiple sclerosis are not clearly understood. However, it is known that the biological response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells. |
| List of Excipients |
|---|
|
Powder: Human albumin Solvent: Sodium chloride |
Powder: 3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal containing 300 microgram (9.6 million IU) of (recombinant interferon beta-1b) powder.
Solvent: 2.25 ml graduated (with dose marks of: 0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml) pre-filled syringe (type I glass) with 1.2 ml solvent.
Pack sizes:
Pack containing 5 vials with powder and 5 pre-filled syringes with solvent
Pack containing 14 vials with powder and 14 pre-filled syringes with solvent
Pack containing 15 vials with powder and 15 pre-filled syringes with solvent
Pack containing 14 vials with powder and 15 pre-filled syringes with solvent
3-month multipack containing 42 (3x14) vials with powder and 42 (3x14) pre-filled syringes with solvent
3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes with solvent
3-month multipack containing 42 (3x14) vials with powder and 45 (3x15) pre-filled syringes with solvent
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/08/454/008-014
Date of first authorisation: 20 May 2008
Date of latest renewal: 20 May 2013
| Drug | Countries | |
|---|---|---|
| EXTAVIA | Austria, Brazil, Canada, Cyprus, Estonia, Spain, France, Croatia, Ireland, Lithuania, Poland, United Kingdom |
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