Xofigo

RSS

radium Ra223 dichloride

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

Overview

Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system).

Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs. It should be used only for patients who have had at least two previous treatments for prostate cancer or who cannot receive other treatments.

Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue’.

Xofigo contains the active substance radium-223 dichloride.

This EPAR was last updated on 11/10/2018

Authorisation details

Product details
Name
Xofigo
Agency product number
EMEA/H/C/002653
Active substance
radium Ra223 dichloride
International non-proprietary name (INN) or common name
radium Ra223 dichloride
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
V10XX03
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Bayer AG
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
13/11/2013
Contact address
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Product information

28/09/2018 Xofigo - EMEA/H/C/002653 - A20/1459/C/2653/0028

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

THERAPEUTIC RADIOPHARMACEUTICALS

Therapeutic indication

Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

Assessment history

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