Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 05 September 2018

Indication(s)

- Protopic 0.03% ointment:
Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.

Flare treatment
Adults and adolescents (16 years of age and above)
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.

Children (2 years of age and above)
Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.

Maintenance treatment
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).



- Protopic 0.1% ointment:
Protopic 0.1 % ointment is indicated in adults and adolescents (16 years of age and above)

Flare treatment
Adults and adolescents (16 years of age and above)
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.

Maintenance treatment
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).

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/000374
Orphan designation No
Date First Approved 28-02-2002
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder LEO Pharma A/S