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EMA approval · 2025-11-27

EMA Authorised: Rolcya (denosumab) — Sandoz GmbH

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Summary

The EMA authorised Rolcya, a denosumab product by Sandoz GmbH, for osteoporosis including postmenopausal osteoporosis.

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Diseases / indications

Drugs mentioned

  • Rolcya (denosumab)

Snippet

Status: Authorised. Therapeutic area: Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption. MAH: Sandoz GmbH. Decision date: 27/11/2025