Calcitonin salmon nasal spray

Trade Name: 
Miacalcin NS, Sandoz Calcitonin NS, Apo-Calcitonin NS
Manufacturer/Distributor: 
Novartis Pharmaceuticals
Sandoz Canada
Apotex Inc.
Classification: 
Bone metabolism regulator
ATC Class: 
H05BA - calcitonin preparation
Status: 
discontinued
Presentation: 
Nasal spray: 200 IU. DIN: 02240775 (Miacalcin)
Nasal spray: 200 IU. DIN: 02261766 (Sandoz Calcitonin NS)
Nasal spray: 200 IU. DIN: 02247585 (Apo-Calcitonin NS)
Comments: 
The manufacturers of synthetic calcitonin (salmon) nasal sprays (Miacalcin – Novartis; Sandoz Calcitonin – Sandoz; Apo-Calcitonin – Apotex) ceased sale of these products on July 3, 2013. Distribution will be phased out and DINs cancelled on October 1, 2013. "Health Canada has evaluated information on the risk of malignancies from randomised controlled trials in patients with osteoporosis or osteoarthritis receiving calcitonin (salmon) nasal spray or an unlicensed oral calcitonin formulation. Patients treated with calcitonin in these trials had a low but observable increased rate of malignancies compared with patients taking placebo. The increased rates seen with calcitonin compared to placebo varied between 0.7% in studies with the oral formulation to 2.4% in the studies with the nasal formulation.Taking this new safety information and the available efficacy data into account, Health Canada concluded that the risks of calcitonin (salmon) nasal spray outweigh the benefits for the treatment of established post-menopausal osteoporosis."
Source: 
Healthy Canadians Website: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34783a-eng.php
Posted Updated
2013-07-31 21:36 2013-07-31 21:41
Browse by keywords: