Prolia

denosumab

Opinion

On 26 April 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prolia. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The CHMP adopted a new indication as follows:

"Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1)."

For information, the full indications for Prolia will be as follows1:

"Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.

Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1)."

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Key facts

Name
Prolia
Agency product number
EMEA/H/C/001120
International non-proprietary name (INN) or common name
  • denosumab
Active substance
  • denosumab
Therapeutic area
Bone Resorption
Osteoporosis, Postmenopausal
Date opinion adopted
26/04/2018
Company name
Amgen Europe B.V.
Status
Positive
Application type
Post-authorisation

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