OXALIPLATIN Concentrate for solution Ref.[7987] Active ingredients: Oxaliplatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Product name and form

Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear, colourless liquid.

pH: 4.5 – 6.5
Osmolarity: approximately 8mOsmol/kg

Qualitative and quantitative composition

1 ml concentrate for solution for infusion contains 5 mg oxaliplatin.

10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin.

20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin.

30 ml of concentrate for solution for infusion contains 150 mg of oxaliplatin.

40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin.

50 ml of concentrate for solution for infusion contains 250 mg of oxaliplatin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Oxaliplatin

Oxaliplatin is an antineoplastic active substance belonging to a new class of platinum-based compounds in which the platinum atom is complexed with 1,2-diaminocyclohexane (“DACH”) and an oxalate group.

List of Excipients

Water for injections

Pack sizes and marketing

Colourless glass vials with grey Halobutyl rubber stoppers and aluminium seals with plastic flip-off caps, with or without a protective plastic overwrap (Onco-Safe).

Pack sizes:

50mg/10ml: 1 vial, 5 vials, 10 vials
100mg/20ml: 1 vial
150mg/30ml: 1 vial
200mg/40ml: 1 vial
250mg/50ml: 1 vial

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Marketing authorization dates and numbers

PL 04416/1604

17/12/2010

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