ETRIVEX Shampoo Ref.[49925] Active ingredients: Clobetasol propionate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Product name and form

Etrivex 500 micrograms/g Shampoo.

Pharmaceutical Form

Shampoo.

Viscous, translucent, colourless to pale yellow liquid shampoo with alcoholic odour.

Qualitative and quantitative composition

One gram of shampoo contains 500 micrograms of clobetasol propionate.

Excipient of known effect: One gram of shampoo contains 100 milligrams of Ethanol.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Clobetasol propionate

Clobetasol propionate, like other topical corticosteroids, has anti-inflammatory, antipruritic, and vasoconstrictive properties. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

List of Excipients

Ethanol
Coco alkyl dimethyl betaine
Sodium laurethsulfate
Polyquaternium-10
Sodium citrate
Citric acid monohydrate
Purified water

Pack sizes and marketing

The product is packaged in high density polyethylene (HDPE) bottles of 60 ml or 125 ml fitted with polypropylene snap closures. The HDPE bottle of 30 ml is fitted with polypropylene screw closure.

Bottles contain 30 ml, 60 ml or 125 ml of shampoo.

1 g of shampoo corresponds to 1 millilitre of shampoo.

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Marketing authorization dates and numbers

PL 10590/0052

28/11/2011

Drugs

Drug Countries
ETRIVEX Ireland, Italy, Malta, United Kingdom

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