Xiapex
Withdrawn
collagenase Clostridium histolyticum
Medicine
Human
Withdrawn
On 5 December 2019, the European Commission withdrew the marketing authorisation for Xiapex (collagenase Clostridium histolyticum) in the European Union (EU). The withdrawal is effective as of 1 March 2020. The withdrawal was at the request of the marketing authorisation holder, Swedish Orphan Biovitrum AB (publ), which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Xiapex was granted marketing authorisation in the EU on 28 February 2011 for treatment of Dupuytren’s contracture/ Peyronie’s disease in adult patients.
The European Public Assessment Report (EPAR) for Xiapex is updated to indicate that the marketing authorisation is no longer valid.
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