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Efficacy of calcitonin in treatment of postmenopausal osteoporosis confirmed.(Miacalcic from Novartis Pharma AG)
2003 JAN 2 - (NewsRx.com & NewsRx.net) -- The European Union's Committee for Propriety Medicinal Products (CPMP) has confirmed the efficacy of calcitonin containing products in the treatment of osteoporosis, following an Article 31 Referral.
The Opinion from the CPMP concerns Miacalcic (salmon calcitonin) from Novartis Pharma AG, which is widely used around the world for the treatment of postmenopausal osteoporosis and other bone disorders.
Today's Opinion will harmonize prescribing advice across the European Union. Article 31 Referrals are used to review medicines marketed in the European Union in the light of new data or information related to quality, safety, and efficacy.
In formally adopting the opinion, the CPMP stated that:
* Intranasal calcitonin - is approved for the treatment of established postmenopausal osteoporosis in order to reduce the risk of vertebral fractures
* Injectable calcitonin - is approved in the prevention of acute bone loss due to sudden immobilization such as in patients with recent osteoporotic fractures. It is also approved for Paget disease and hypercalcemia of malignancy
The CPMP also states that in the intranasal formulation, a reduction in hip fractures has not been demonstrated and this will be highlighted within the new prescribing information.
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