Protopy

Withdrawn

This medicine's authorisation has been withdrawn

tacrolimus

Overview

On 28 February 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Protopy (Tacrolimus), 0.03% and 0.1% ointment for cutaneous use, which have been approved for treatment of moderate to severe atopic dermatitis. The marketing authorisation holder (MAH) responsible for Protopy is Astellas Pharma GmBH. 

The European Commission was notified by the MAH of its decision through the MAH’s letter dated 27 June 2008 to voluntarily withdraw the marketing authorisation for Protopy for commercial reasons. Protopy was never marketed anywhere in the European Union (EU). Protopic is an identical product available in the EU. On 22 August 2008 the European Commission issued a decision to withdraw the marketing authorisation for Protopy. 

Pursuant to this decision the European Public Assessment Report for Protopy is updated to reflect that the marketing authorisation is no longer valid.

Protopy : EPAR - Summary for the public

Product information

Protopy : EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  22/08/2008
• 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