VINORELBINE Concentrate for solution for infusion Ref.[9077] Active ingredients: Vinorelbine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Vinorelbine 10 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

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

pH in the range of approximately 3.0 to 4.0 and osmolality in the range of approximately 30 to 40 mOsm/Kg.

Qualitative and quantitative composition

1 ml of solution contains 10 mg vinorelbine (as vinorelbine tartrate).

Each 1 ml vial contains a total of 10 mg vinorelbine (as tartrate).

Each 5 ml vial contains a total of 50 mg vinorelbine (as tartrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description

Vinorelbine is an antineoplastic drug of the vinca alkaloid family but unlike all the other vinca alkaloids. Vinorelbine inhibits tubulin polymerization and blocks mitosis at G2-M, causing cell death in interphase or at the following mitosis.

List of Excipients

Water for injection.

Pack sizes and marketing

Vinorelbine solution is packaged in Type I clear glass vial with bromobutyl rubber stopper and aluminium flip off blue seal.

Vinorelbine solution is available in:

Vial – 1 unit(s) - 1 ml
Vial – 1 unit(s) - 5 ml

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 20075/0450


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