PROTOPIC 0.1% Ointment Ref.[7763] Active ingredients: Tacrolimus

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: LEO Pharma A/S, Industriparken 55 2750, Ballerup, Denmark

Product name and form

Protopic 0.1% ointment.

Pharmaceutical Form

Ointment.

A white to slightly yellowish ointment.

Qualitative and quantitative composition

1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).

Excipient with known effect: Butylhydroxytoluene (E321) 15 micrograms/g ointment. For the full list of excipients, see section 6.1.

Active Ingredient Description
Tacrolimus

Tacrolimus is a highly potent immunosuppressive agent. In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.

List of Excipients

White soft paraffin
Liquid paraffin
Propylene carbonate
White beeswax
Hard paraffin
Butylhydroxytoluene (E321)
All-rac-α-tocopherol

Pack sizes and marketing

Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.

Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.

Marketing authorization holder

LEO Pharma A/S, Industriparken 55 2750, Ballerup, Denmark

Marketing authorization dates and numbers

EU/1/02/201/003
EU/1/02/201/004
EU/1/02/201/006

Date of first authorisation: 28 February 2002
Date of latest renewal: 20 November 2006

Drugs

Drug Countries
PROTOPIC Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom, United States

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