NAVILIN Capsule Ref.[51234] Active ingredients: Vinorelbine

Source: Health Products Regulatory Authority (ZA)  Publisher: Eurolab (Pty) Ltd., Woodmead Office Park, 3 Stirrup Lane, Van Reenens Avenue, Woodmead, 2144

Product name and form

NAVILIN 20 Soft capsules.

NAVILIN 30 Soft capsules.

Pharmaceutical Form

NAVILIN 20: An oval-shaped light brown soft capsule.

NAVILIN 30: An oblong-shaped pink soft capsule.

Qualitative and quantitative composition

Each NAVILIN 20 soft capsule contains 27,70 mg vinorelbine tartrate equivalent to 20 mg vinorelbine base.

Each NAVILIN 30 soft capsule contains 41,55 mg vinorelbine tartrate equivalent to 30 mg vinorelbine base.

NAVILIN contains Polysorbate 80 and the capsule shell contains sorbitol liquid partially dehydrated (EP).

NAVILIN is sugar free.

Active Ingredient Description
Vinorelbine

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

The inactive ingredients include macrogol 400, polysorbate 80 and purified water.

The 20 mg capsule shell contains gelatin 160, iron oxide yellow (E172), purified water, sorbitol liquid partially dehydrated (EP), titanium dioxide (E171), triglycerides (medium chain).

The 30 mg capsule shell contains gelatin 160, iron oxide red (E172), purified water, sorbitol liquid partially dehydrated (EP), titanium dioxide (E171), triglycerides (medium chain).

Pack sizes and marketing

NAVILIN is packed in PVC/PVDC-Al blister with child-resistant safety paper layer. The blister is further packed in an outer carton.

Pack size: 1 capsule.

Marketing authorization holder

Eurolab (Pty) Ltd., Woodmead Office Park, 3 Stirrup Lane, Van Reenens Avenue, Woodmead, 2144

Marketing authorization dates and numbers

NAVILIN 20: A 53/26/0743
NAVILIN 30: A 53/26/0744

Not applicable.

Drugs

Drug Countries
NAVILIN South Africa

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