Source: European Medicines Agency (EU) | Revision Year: 2019 | Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP, Badhoevedorp, The Netherlands
AVONEX 30 micrograms/0.5 ml solution for injection.
Solution for injection.
Clear and colourless solution.
Each 0.5 ml pre-filled syringe contains 30 micrograms (6 million IU) of interferon beta-1a.
The concentration is 30 micrograms per 0.5 ml.
Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contain 6 million IU of antiviral activity. The activity against other standards is not known.
Excipient(s) with known effect: For the full list of excipients, see section 6.1.
Interferon beta-1a exerts its biological effects by binding to specific receptors on the surface of human cells. This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers. Whether the mechanism of action of interferon beta-1a in MS is mediated by the same pathway as the biological effects described above is not known because the pathophysiology of MS is not well established.
Sodium acetate trihydrate
Acetic acid, glacial
Water for injections
1 ml pre-filled syringe made of glass (Type I) with a tamper evident cap and plunger stopper (bromobutyl) containing 0.5 ml of solution.
Pack size: box of four or twelve pre-filled syringes of 0.5 ml. Each syringe is packed in a sealed plastic tray, which also contains one injection needle for intramuscular use.
Not all pack sizes may be marketed.
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP, Badhoevedorp, The Netherlands
Date of first authorisation: 13 March 1997
Date of latest renewal: 13 March 2007
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