DEPOCYTE Suspension for injection Ref.[2692] Active ingredients: Cytarabine

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

Product name and form

DepoCyte 50 mg suspension for injection.

Pharmaceutical Form

Suspension for injection.

White to off-white suspension.

Qualitative and quantitative composition

One ml of suspension contains 10 mg cytarabine.

Each 5 ml vial contains 50 mg cytarabine.

For a full list of excipients, see section 6.1.

Active Ingredient Description

Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes.

List of Excipients

Dioleoylphosphatidylcholine (DOPC)
Dipalmitoylphosphatidylglycerol (DPPG)
Sodium chloride
Water for injections

Pack sizes and marketing

Type I glass vial closed with a fluororesin faced butyl rubber stopper and sealed with an aluminium flip-off seal containing 50 mg cytarabine in 5 ml suspension.

DepoCyte is supplied in individual cartons each containing one single-dose vial.

Marketing authorization holder

Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

Marketing authorization dates and numbers


Date of first authorisation: 11 July 2001
Date of latest renewal: 11 July 2011


Drug Countries
DEPOCYTE Estonia, Lithuania

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