IVOZALL Concentrate for solution for infusion Ref.[49843] Active ingredients: Clofarabine

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: ORPHELIA Pharma, 85 boulevard Saint-Michel, 75005 PARIS, France

Product name and form

Ivozall 1 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

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

Qualitative and quantitative composition

Each ml of concentrate contains 1 mg of clofarabine.

Each 20 ml vial contains 20 mg of clofarabine.

Excipient with known effect: Each 20 ml vial contains 70.77 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient 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 grey chlorobutyl fluoropolymer coated 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 vial.

Marketing authorization holder

ORPHELIA Pharma, 85 boulevard Saint-Michel, 75005 PARIS, France

Marketing authorization dates and numbers

EU/1/19/1396/001

Date of first authorisation: 14 November 2019

Drugs

Drug Countries
IVOZALL Austria, Estonia, France, Ireland, Lithuania, Poland

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