CERUBIDIN Powder for concentrate for solution for infusion Ref.[51399] Active ingredients: Daunorubicin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Cerubidin 20 mg Powder for Concentrate for Solution for Infusion.

Pharmaceutical Form

Powder for concentrate for Solution for Infusion.

A microcrystalline, orange-red, sterile powder.

Qualitative and quantitative composition

Daunorubicin Hydrochloride equivalent to Daunorubicin 20 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Daunorubicin

Daunorubicin is an anthracycline glycoside antibiotic and is a potent antileukaemic agent. It also has immunosuppressant effects. Daunorubicin may involve binding to DNA by intercalation between base pairs and inhibition of DNA and RNA synthesis by template disordering and steric obstruction.

List of Excipients

D-Mannitol

Pack sizes and marketing

Uncoloured Type III (Ph. Eur.) neutral glass vial fitted with butyl rubber stopper and aluminium overseal. The vials are available in packs of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/096/001

Date of first authorisation: 20 April 1995
Date of last renewal: 20 April 2010

Drugs

Drug Countries
CERUBIDIN Ireland, Malta

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