TRETINOIN Capsule Ref.[7135] Active ingredients: Tretinoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: CHEPLAPHARM Arzneimittel GmbH, Bahnhofstr. 1a, 17498 Mesekenhagen, Germany

Product name and form

Vesanoid 10 mg soft capsules.

Tretinoin 10mg soft capsules.

Pharmaceutical Form

Capsule, soft.

Oval, bi-coloured orange-yellow/reddish-brown capsules.

Qualitative and quantitative composition

Active substance:

1 soft capsule contains 10 mg of tretinoin (all-trans retinoic acid, ATRA).

Excipients with known effect:

1 soft capsule contains 107.92 mg of soya-bean oil.

The capsule-shell contains between 1.93–2.94 mg of sorbitol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tretinoin

Tretinoin decreases cohesiveness of follicular epithelial cells resulting in decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of the comedones.

List of Excipients

Capsule contents:

Yellow beeswax
Hydrogenated soya-bean oil
Partially hydrogenated soya-bean oil
Soya-bean oil

Capsule shell:

Gelatin
Glycerol (E422)
Karion 83: Sorbitol, Mannitol, Starch (maize)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)

Pack sizes and marketing

Amber glass bottles of 100 capsules.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Bahnhofstr. 1a, 17498 Mesekenhagen, Germany

Marketing authorization dates and numbers

PL 27041/0003

Date of first authorisation: 22 October 1996
Date of latest renewal: 17 August 2006

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