Optruma

RSS

raloxifene

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 its 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 17/11/2017

Authorisation details

Product details
Name
Optruma
Agency product number
EMEA/H/C/000185
Active substance
raloxifene hydrochloride
International non-proprietary name (INN) or common name
raloxifene
Therapeutic area (MeSH)
Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
G03XC01
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
05/08/1998
Contact address
Eli Lilly Nederland BV
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

03/08/2017 Optruma - EMEA/H/C/000185 - IAIN/0071

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

Sex hormones and modulators of the genital system

Therapeutic indication

Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

Assessment history

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