EPARs human use - Protopic//Tacrolimus (as monohydrate)

FICHA FARMACOLÓGICA de Tacrolimus (as monohydrate). Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JULIO 06, 2009.-
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EPARs for authorised medicinal products for human use - Protopic

Active Substance
Tacrolimus (as monohydrate)
International Nonproprietary Name or Common Name
Tacrolimus
Pharmaco-therapeutic Group
Other dermatologicals
ATC Code
D11AX14

Therapeutic Indication:
For Protopic 0.1% ointment:
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.

For Protopic 0.03% ointment:
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.

Date of issue of Marketing Authorisation valid throughout the European Union
28 February 2002

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use