ELIDEL Cream Ref.[8464] Active ingredients: Pimecrolimus

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Elidel 10mg/g cream.

Pharmaceutical Form

Cream.

Whitish and homogeneous.

Qualitative and quantitative composition

1 g of cream contains 10 mg of pimecrolimus.

Excipients with known effect: 10 mg benzyl alcohol, 40 mg cetyl alcohol, 40 mg stearyl alcohol, and 50 mg propylene glycol (E 1520) in 1 g of cream.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Pimecrolimus

Pimecrolimus is a lipophilic anti-inflammatory ascomycin macrolactam derivative and a cell selective inhibitor of the production and release of pro-inflammatory cytokines.

List of Excipients

Medium chain triglycerides
Oleyl alcohol
Propylene glycol (E1520)
Stearyl alcohol
Cetyl alcohol
Mono-and di-glycerides
Sodium cetostearyl sulphate
Benzyl alcohol
Citric acid anhydrous
Sodium hydroxide
Purified water

Pack sizes and marketing

Aluminium tube with a phenol-epoxy protective inner lacquer and polypropylene screw cap.

Tubes of 5, 15, 30, 60 and 100 grams.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0163

1 August 2013

Drugs

Drug Countries
ELIDEL Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Israel, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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