Theryttrex

Withdrawn

This medicine's authorisation has been withdrawn

yttrium [90Y] chloride

Overview

On 7 January 2003 the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Theryttrex radiopharmaceutical precursor, solution, intended for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide. This decision was based on the assessment report and on the favourable opinion adopted by the Committee for Proprietary Medicinal Products (CPMP) on 19 September 2002. 

The Marketing Authorisation Holder responsible for this medicinal product is MDS Nordion S.A., Belgium. Theryttrex was authorised “to be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide. Radiopharmaceutical precursor – Not intended for direct use in patients”, only by specialists with the appropriate experience. Theryttrex has not been marketed anywhere in the EU. 

On 22 November 2005, MDS Nordion S.A. notified the European Commission of its decision to withdraw the Community Marketing Authorisation for Theryttrex for commercial reasons. 

On 2 February 2006, the European Commission issued a decision to withdraw the Marketing Authorisation for Theryttrex. Consequently, the European Public Assessment Report for Theryttrex has been removed from this website.

Product information

Product details

• Name of medicine:
  Theryttrex
• Active substance:
  yttrium (90Y) chloride
• International non-proprietary name (INN) or common name:
  yttrium [90Y] chloride
• Therapeutic area (MeSH):
  Radionuclide Imaging
• Anatomical therapeutic chemical (ATC) code:
  V09

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Radiopharmaceutical precursor - Not intended for direct application to patients.

Authorisation details

• EMA product number:
  EMEA/H/C/000445
• Marketing authorisation holder:
  MDS Nordion S.A.

  Zoning Industriel; B-6220 Fleurus; Belgium

• Marketing authorisation issued:
  07/01/2003
• Withdrawal of marketing authorisation:
  02/02/2006
• Revision:
  1