CARBOPLATIN Solution for infusion Ref.[6526] Active ingredients: Carboplatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord Healthcare Limited, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Carboplatin 10 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

A clear, colourless to slightly pale yellow solution free from particles.

Qualitative and quantitative composition

1 ml of concentrate for solution for infusion contains 10mg of Carboplatin.

Each 5 ml vial contains 50 mg carboplatin.
Each 15 ml vial contains 150 mg carboplatin.
Each 45 ml vial contains 450 mg carboplatin.
Each 60 ml vial contains 600 mg carboplatin.

For a full list of excipients, see section 6.1.

Active Ingredient
List of Excipients

Water for injections

Pack sizes and marketing

Carboplatin infusion is supplied in 5 ml/15 ml/50 ml/100 ml type I amber glass vial containing 5 ml/15 ml/45 ml/60 ml concentrate for solution respectively. Vials are closed using grey chlorobutyl rubber stopper/Grey Westar prewashed rubber stopper with an aluminium flip off seal.

1 glass vial in one monocarton
5 ml vial, containing 50mg of carboplatin, 10mg/ml.
15 ml vial, containing 150 mg of carboplatin, 10mg/ml.
50 ml vial, containing 450 mg carboplatin, 10mg/ml.
100 ml vial, containing 600 mg carboplatin, 10mg/ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0028


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