Protopy
Withdrawn
This medicine's authorisation has been withdrawn
tacrolimus
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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decision the European Public Assessment Report for Protopy is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
II/0028
03/05/2007
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
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 preparationsTherapeutic 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
This page was last updated on