Source: European Medicines Agency (EU) | Revision Year: 2020 | Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
IntronA 10 million IU/mL solution for injection or infusion.
Solution for injection or infusion.
Clear and colourless solution.
One vial of solution for injection or infusion contains 10 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1 mL of solution.
For the full list of excipients, see section 6.1.
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.
Disodium phosphate anhydrous
Sodium dihydrogen phosphate monohydrate
Water for injections
1 mL of solution (corresponding to 10 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
IntronA is supplied as:
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Date of first authorisation: 9 March 2000
Date of latest renewal: 9 March 2010
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