This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Protopy has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 29/10/2008

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Dermatitis, Atopic
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Astellas Pharma GmbH
Date of issue of marketing authorisation valid throughout the European Union
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

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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).

Assessment history

Changes since initial authorisation of medicine

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