This is a summary of the European public assessment report (EPAR) for Protopic. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protopic.
Therapeutic Indication
### Therapeutic indication **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 (two years of age and above) Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. **Maintenance treatment** 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 four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Therapeutic Area (MeSH)
ATC Code
D11AH01
ATC Item
tacrolimus
Pharmacotherapeutic Group
Other dermatological preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| tacrolimus | N/A | 他克莫司 |
EMA Name
Protopic
Medicine Name
Protopic
Aliases
N/ANo risk management plan link.
