Table of contents
The marketing authorisation for Protopy has been withdrawn at the request of the marketing authorisation holder.
Protopy : EPAR - Summary for the public (PDF/259.28 KB)
First published: 29/10/2008
Last updated: 29/10/2008
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Astellas Pharma GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
Astellas Pharma Europe B.V.
NL-2353 EW Leiderdorp
03/05/2007 Protopy - EMEA/H/C/000375 - II/0028
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- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Other dermatological preparations
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).