This medicine is now known as glucarpidase.
On 3 February 2003, orphan designation (EU/3/02/128) was granted by the European Commission to Enact Pharma plc, United Kingdom, for carboxypeptidase G2 for the adjunctive treatment in patients at risk of methotrexate toxicity.
The sponsorship was transferred to Protherics PLC, United Kingdom, in December 2004 and subsequently to Protherics Medicines Development Europe B.V., the Netherlands, in March 2020.
The sponsorship was transferred to Serb, France in July 2021.
The medicinal product has been authorised in the EU as Voraxaze since 11 January 2022
Carboxypeptidase G2 (glucarpidase)
Adjunctive treatment in patients at risk of methotrexate toxicity
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Review of designation
Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: