TYSABRI Concentrate for solution for infusion Ref.[8303] Active ingredients: Natalizumab

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands

Product name and form

TYSABRI 300 mg concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Colourless, clear to slightly opalescent solution.

Qualitative and quantitative composition

Each ml of concentrate contains 20 mg of natalizumab.

When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab.

Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology.

Excipient with known effect: Each vial contains 2.3 mmol (or 52 mg) sodium. When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Natalizumab

Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.

List of Excipients

Sodium phosphate, monobasic, monohydrate
Sodium phosphate, dibasic, heptahydrate
Sodium chloride
Polysorbate 80 (E433)
Water for injections

Pack sizes and marketing

15 ml concentrate in a vial (type I glass) with a stopper (chlorobutyl rubber) and a seal (aluminium) with a flip-off cap.

Pack size of one vial per carton.

Marketing authorization holder

Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands

Marketing authorization dates and numbers

EU/1/06/346/001

Date of first authorisation: 27th June 2006
Date of latest renewal: 18th April 2016

Drugs

Drug Countries
TYSABRI Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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