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, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom, United States
 
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