ADVANTAN Cream, Ointment Ref.[50852] Active ingredients: Methylprednisolone

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: LEO Pharma Limited, Auckland, New Zealand, Toll Free No. 0800 497 456

Product name and form

ADVANTAN.

Cream: ADVANTAN methylprednisolone aceponate 0.1% cream.

Ointment: ADVANTAN methylprednisolone aceponate 0.1% ointment.

Pharmaceutical Form

Topical cream.

Topical ointment.

Qualitative and quantitative composition

1 g cream or ointment contains 1 mg (0.1%) methylprednisolone aceponate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Methylprednisolone

Methylprednisolone is a synthetic glucocorticoid and a methyl derivative of prednisolone. Methylprednisolone is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system.

List of Excipients

Cream: decyl oleate, glycerol monostearate 40–55%, cetostearyl alcohol, hard fat, caprylic-capricstearic acid triglyceride (Softisan 378), polyoxyl-40-stearate, glycerol 85%, disodium edetate, benzyl alcohol, butyl hydroxytoluene, purified water.

Ointment: beeswax (white), paraffin, liquid, Dehymuls E, paraffin (white soft), purified water.

Pack sizes and marketing

Tubes containing 15 g.

Tubes are made of pure aluminium; interior walls are coated with epoxy resin, and with a polyesterbased external coating. The fold seal ring is made of polyamide-based heat-sealable material. The screw cap is made of high-density polyethylene.

Marketing authorization holder

LEO Pharma Limited, Auckland, New Zealand, Toll Free No. 0800 497 456

Marketing authorization dates and numbers

Cream and ointment: 26 March 1992

Drugs

Drug Countries
ADVANTAN Austria, Australia, Brazil, Cyprus, Germany, Estonia, Finland, Hong Kong, Croatia, Lithuania, Malta, Mexico, New Zealand, Poland, Romania, Turkey, United Kingdom, South Africa

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