Source: European Medicines Agency (EU) Revision Year: 2008 Publisher: SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
Viraferon 1 million IU/ml powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. White to cream coloured powder. Clear and colourless solvent. |
One vial of powder contains 1 million IU of interferon alfa-2b produced in E.coli by recombinant DNA technology.
After reconstitution, 1 ml contains 1 million IU of interferon alfa-2b.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Interferon, alfa-2b |
Recombinant interferon alfa-2b is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques. Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface. Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals. It has demonstrated significant immunomodulatory activity in vitro. |
| List of Excipients |
|---|
|
Glycine Solvent: water for injections |
24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab. Pack sizes of 1.
Not all pack sizes may be marketed.
SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
EU/1/99/128/001
Date of first authorisation: 9 March 2000
Date of last renewal: 23 May 2005
| Drug | Countries | |
|---|---|---|
| VIRAFERON | Ireland, South Africa |
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