VINORELBINE Soft capsule Ref.[9075] Active ingredients: Vinorelbine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Consilient Health Limited, 5<sup>th</sup> Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Product name and form

Vinorelbine 20 mg soft capsules.

Pharmaceutical Form

Soft capsule.

An oval-shaped light brown soft capsule, with dimensions of 11.3mm (±1.0mm) x 6.7mm (±1.0mm).

Qualitative and quantitative composition

Each soft capsule contains 20 mg vinorelbine (as tartrate).

Excipient with known effect: Each soft capsule containing 20 mg vinorelbine contains 38.44 mg sorbitol

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

Capsule content:

Macrogol 400
Polysorbate 80 (E433)
Purified water

Capsule shell:

Partially dehydrated sorbitol liquid( E420)
Titanium dioxide (E171)
Purified water
Iron oxide yellow (E172)

Pack sizes and marketing

Carton box containing a PVC/PVDC-Aluminium blister with child-resistant safety paper layer.

Carton box containing an OPA/Aluminium/PVC-Aluminium blister.

Pack size: 1 or 4 blisters containing 1 soft capsule each. Not all pack sizes may be marketed.

Marketing authorization holder

Consilient Health Limited, 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Marketing authorization dates and numbers

PL 24837/0094


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