EU/3/02/128: Orphan designation for the adjunctive treatment in patients at risk of methotrexate toxicity

Carboxypeptidase G2 (glucarpidase)

Overview

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

Key facts

Active substance
Carboxypeptidase G2 (glucarpidase)
Intended use
Adjunctive treatment in patients at risk of methotrexate toxicity
Orphan designation status
Positive
EU designation number
EU/3/02/128
Date of designation
03/02/2003
Sponsor

SERB
40 avenue George V
75008 Paris
France
Tel. +33 1 73 03 20 17
E-mail: regulatory@serb.eu

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Voraxaze at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the Orphan Medicine Assessment Report

 

Documents related to this orphan designation evaluation

Patients' organisations

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:

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