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news.Astella Pharma Europe, a subsidiary of Astellas Pharma, is going to launch Protopic ointment in Europe. The company is waiting for the approval of Protopic ointment (tacrolimus monohydrate), a topical calcineurin inhibitor for treatment of eczema.
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Protopic ointment is licensed to teat severe eczema (atopic dermatitis), and approved for twice-weekly application by the patients.
Protopic ointment’s approval was based on the data demonstrated by two phase-III studies (CONTROL) conducted in 524 adults and children in 13 European countries. The result demonstrated that once patients had responded to twice-daily treatment of their flares with Protopic ointment, continuing treatment to previously affected areas with a twice-weekly regimen significantly reduced the number of flares compared to a flare treatment-only regimen.
Protopic ointment has been marketed in Europe for the treatment of moderate to severe atopic dermatitis in adults and children aged two and over, since 2001.