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Evoltra 1mg/ml concentrate for solution for infusion (2011)

Active ingredients: Clofarabine

Product Name and Form

Evoltra 1 mg/ml concentrate for solution for infusion.

Pharmaceutical form

Concentrate for solution for infusion.

Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.

Qualitative and Quantitative Composition

Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine.

Excipient: Each 20 ml vial contains 180 mg of sodium chloride.

For a full list of excipients, see section 6.1.

Chemical substance
Description
Clofarabine

Clofarabine is a purine nucleoside anti-metabolite. Its antitumour activity is believed to be due to 3 mechanisms. Clofarabine produces DNA polymerase inhibition resulting in termination of DNA chain elongation and/or DNA synthesis/repair and ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools. Clofarabine also produces disruption of mitochondrial membrane integrity with the release of cytochrome C and other proapoptotic factors leading to programmed cell death even in non-dividing lymphocytes.

List of excipients

Sodium chloride
Water for injections

Pack sizes and Marketing

Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal. The vials contain 20 ml concentrate for solution for infusion and are packaged in a box. Each box contains 1, 3, 4, 10 or 20 vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Genzyme Europe BV
Gooimeer 10
1411DD Naarden
The Netherlands

Tel: +31 (0)35 699 12 00
Fax: +31 (0) 35 694 32 14

Date of first authorisation: 29 May 2006

Date of latest renewal: 24 March 2011

Marketing authorization number:

EU/1/06/334/001 3 vials

EU/1/06/334/002 4 vials

EU/1/06/334/003 10 vials

EU/1/06/334/004 20 vials

EU/1/06/334/005 1 vial