Ytracis

RSS

yttrium [90Y] chloride

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 10/07/2015

Authorisation details

Product details
Name
Ytracis
Agency product number
EMEA/H/C/000460
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
Publication details
Marketing-authorisation holder
CIS bio international
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
24/03/2003
Contact address

Route Nationale 306, Saclay
B.P. 32
F-91192 Gif sur Yvette Cedex
France

Product information

29/05/2015 Ytracis - EMEA/H/C/000460 - IAIN/0016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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