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Protopy

Active Substance: tacrolimus
Common Name: tacrolimus
ATC Code: D11AX14
Marketing Authorisation Holder: Astellas Pharma GmbH
Active Substance: tacrolimus
Status: Withdrawn
Authorisation Date: 2002-02-28
Therapeutic Area: Dermatitis, Atopic
Pharmacotherapeutic Group: Other dermatological preparations

Therapeutic Indication

Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

The marketing authorisation for Protopy has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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