CINACALCIP (Cipla Australia Pty Ltd)
Product name
CINACALCIP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
83 (255 working days)
Active ingredients
Cinacalcet hydrochloride
Registration type
New generic medicine
Indication
CINACALCIP may be used to treat the biochemical manifestations of secondary hyperparathyroidism (HPT) in patients with end stage renal disease, receiving dialysis (see section 5.1 Pharmacodynamic properties, Clinical trials). [TRADE NAME] should be used as adjunctive therapy.
CINACALCIP is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.
CINACALCIP may be used to treat the biochemical manifestations of primary HPT in patients for whom parathyroidectomy is not a treatment option.