DepoCyte 50 mg 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
Authorization Dates

Pacira Limited
3 Glory Park Avenue
Wooburn Green
High Wycombe
Buckinghamshire
HP10 0DF
United Kingdom

Date of first authorisation: 11 July 2001

Marketing authorization number:

EU/1/01/187/001