ZAVEDOS Capsules Ref.[9082] Active ingredients: Idarubicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Product name and form

Zavedos 5 mg Capsules.

Pharmaceutical Form

Opaque red cap and body, self-locking, hard gelatin capsules, size no. 4, containing an orange powder.

Qualitative and quantitative composition

Idarubicin Hydrochloride 5.0 mg HSE.

Active Ingredient Description
Idarubicin

Idarubicin is a DNA intercalating anthracycline which interacts with the enzyme topoisomerase II and has an inhibitory effect on nucleic acid synthesis. Idarubicin has been shown to have a higher potency with respect to daunorubicin and to be an effective agent against murine leukaemia and lymphomas both by i.v. and oral routes.

List of Excipients

Microcrystalline cellulose Ph. Eur.
Glyceryl palmito-stearate HSE

Capsule shell:

Red iron oxide (E172) FP
Titanium dioxide (E171) Ph. Eur.
Gelatin Ph. Eur.
Sodium dodecyl sulfate Ph. Eur.

Printing ink:

Shellac
Black Iron Oxide (E172)
Propylene Glycol

Pack sizes and marketing

Type III amber glass bottles closed with an aluminium screw cap with a polyethylene gasket and a polyethylene cover cap. Aluminium/aluminium strips.

Pack size: 1.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/1064

10th May 2002

Drugs

Drug Countries
ZAVEDOS Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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