Krystexxa
Withdrawn
This medicine's authorisation has been withdrawn
pegloticase
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 30 June 2016 the European Commission withdrew the marketing authorisation for Krystexxa (pegloticase) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Crealta Pharmaceuticals Ireland Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Krystexxa was granted marketing authorisation in the EU on 8 January 2013 for treatment of chronic gout. The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Krystexxa is updated accordingly to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:PSUSA/00010046/201501
30/06/2016
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).
Product details
- Name of medicine
- Krystexxa
- Active substance
- pegloticase
- International non-proprietary name (INN) or common name
- pegloticase
- Therapeutic area (MeSH)
- Gout
- Anatomical therapeutic chemical (ATC) code
- M04AX02
Pharmacotherapeutic group
Antigout preparationsTherapeutic indication
Krystexxa is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
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