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TACROLIMUS INTAS/ AZEMATOP (Accord Healthcare Pty Ltd)
Product name
TACROLIMUS INTAS/ AZEMATOP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
208 (255 working days)
Active ingredients
tacrolimus monohydrate
Registration type
EOI
Indication
Tacrolimus Intas 0.1% / AZematop 0.1% ointment is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents (16 years of age and above).
Flare treatment
Treatment of moderate to severe flares of atopic dermatitis in patients who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Maintenance treatment
Prevention of flares and prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations who have responded to tacrolimus treatment during flares.