Protopy
tacrolimus
Table of contents
Overview
The marketing authorisation for Protopy has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Protopy
|
| Agency product number |
EMEA/H/C/000375
|
| Active substance |
tacrolimus
|
| International non-proprietary name (INN) or common name |
tacrolimus
|
| Therapeutic area (MeSH) |
Dermatitis, Atopic
|
| Anatomical therapeutic chemical (ATC) code |
D11AX14
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Astellas Pharma GmbH
|
| Revision |
10
|
| Date of issue of marketing authorisation valid throughout the European Union |
28/02/2002
|
| Contact address |
Astellas Pharma Europe B.V.
Elisabethhof 19 NL-2353 EW Leiderdorp The Netherlands |
Product information
03/05/2007 Protopy - EMEA/H/C/000375 - II/0028
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Other dermatological preparations
Therapeutic 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).