Ytracis
Withdrawn
This medicine's authorisation has been withdrawn
yttrium [90Y] chloride
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 20 December 2021, the European Commission withdrew the marketing authorisation for Ytracis (yttrium (90Y) chloride) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, CIS BIO International, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Ytracis was granted marketing authorisation in the EU on 24 March 2003 for radiolabelling of carrier molecules. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2008. The product had not been marketed in the EU since 2021.
Ytracis is an identical product to Yttriga (yttrium (90Y) chloride), which is authorised in the EU to be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
The European Public Assessment Report (EPAR) for Ytracis is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IAIN/0016
29/05/2015
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
- Ytracis
- 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 radiopharmaceuticalsTherapeutic 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.
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