Protopy

Withdrawn

This medicine's authorisation has been withdrawn

tacrolimus

Overview

The marketing authorisation for Protopy has been withdrawn at the request of the marketing authorisation holder.

Protopy : EPAR - Summary for the public

Product information

Protopy : EPAR - Product Information

Latest procedure affecting product information: II/0028

03/05/2007

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).

Protopy : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Protopy
• Active substance:
  tacrolimus
• International non-proprietary name (INN) or common name:
  tacrolimus
• Therapeutic area (MeSH):
  Dermatitis, Atopic
• Anatomical therapeutic chemical (ATC) code:
  D11AX14

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000375
• Marketing authorisation holder:
  Astellas Pharma GmbH

  Astellas Pharma Europe B.V.; Elisabethhof 19; NL-2353 EW Leiderdorp; The Netherlands

• Marketing authorisation issued:
  28/02/2002
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Protopy : EPAR - Procedural steps taken and scientific information after authorisation

Protopy : EPAR - Scientific Conclusion

Protopy : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Protopy : EPAR - Scientific Discussion

Protopy : EPAR - Procedural steps taken before authorisation