ELDISINE Powder for solution for injection Ref.[9071] Active ingredients: Vindesine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Genus Pharmaceuticals Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Product name and form

Eldisine Powder for Solution for Injection 5.0 mg.

Pharmaceutical Form

Powder for Solution for Injection.

A clear glass vial containing a lyophilised plug of white crystalline powder.

Qualitative and quantitative composition

Eldisine Powder 5mg contains 5mg vindesine sulphate per 5ml when reconstituted.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Vindesine

Vindesine is an antineoplastic agent derived from vinblastine, like the other vinca alkaloids it causes mitotic arrest in metaphase by binding to microtubular protein.

List of Excipients

Mannitol
Sulphuric acid (diluted)
Sodium hydroxide (diluted)

Pack sizes and marketing

Single vials comprising Type I glass each with a rubber stopper, an aluminium sealing ring and a polypropylene cap.

Marketing authorization holder

Genus Pharmaceuticals Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Marketing authorization dates and numbers

PL 06831/0117

17/03/2009

Drugs

Drug Countries
ELDISINE Austria, France, Italy, United Kingdom

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