Evoltra 1mg/ml concentrate for solution for infusion

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.

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

Genzyme Europe BV
Gooimeer 10
1411DD Naarden
The Netherlands

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

Marketing authorization dates and numbers

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

Date of first authorisation: 29 May 2006

Date of latest renewal: 24 March 2011

Drugs

Drug
Countries
Austria, Cyprus, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom