Optruma

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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 14/01/2022

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
25
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

13/01/2022 Optruma - EMEA/H/C/000185 - N/0078

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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