Optruma
Withdrawn
This medicine's authorisation has been withdrawn
raloxifene
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 26 March 2026, the European Commission withdrew the marketing authorisation for Optruma (raloxifene) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Eli Lilly Nederland B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Optruma was granted marketing authorisation in the EU on 5 August 1998 for treatment and prevention of osteoporosis. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2003. It was then granted unlimited validity in 2008.
There are other generic medicinal products of raloxifene authorised and marketed in the EU. Optruma is an identical product to Raloxifene Teva, which is authorised in the EU to treat osteoporosis in postmenopausal women. Optruma was a duplicate application to Evista, which is marketed in several EU countries.
Product information
Latest procedure affecting product information:VR/0000315293
27/01/2026
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
- Optruma
- Active substance
- raloxifene hydrochloride
- International non-proprietary name (INN) or common name
- raloxifene
- Therapeutic area (MeSH)
- Osteoporosis, Postmenopausal
- Anatomical therapeutic chemical (ATC) code
- G03XC01
Pharmacotherapeutic group
Sex hormones and modulators of the genital systemTherapeutic 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).
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