Protopy (tacrolimus)
- Region
- 🇪🇺 EU
- Active substance
- tacrolimus
- Company
- Astellas Pharma GmbH
- Status
- Withdrawn
- Therapeutic area
- Dermatitis, Atopic
- EU approval
- Thu 28 Feb 2002
- Application
- EMEA/H/C/000375
- ATC
- D11AX14
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Advagraf Authorised · Astellas Pharma Europe BV
- 🇪🇺 Protopic Authorised · LEO Pharma A/S
- 🇪🇺 Tacforius Authorised · Teva B.V.
- 🇪🇺 Envarsus Authorised · Chiesi Farmaceutici S.p.A.
- 🇪🇺 Modigraf Authorised · Astellas Pharma Europe B.V.
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