DEPOCYTE Suspension for injection

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.

List of Excipients

Cholesterol
Triolein
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

EU/1/01/187/001

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

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