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CINACALCET MYLAN (Alphapharm Pty Ltd)
Product name
CINACALCET MYLAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
147 working days (255)
Active ingredients
cinacalcet hydrochloride
Registration type
New generic medicine
Indication
CINACALCET MYLAN (tablet) may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see CLINICAL TRIALS). CINACALCET MYLAN should be used as adjunctive therapy.
CINACALCET MYLAN is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.
CINACALCET MYLAN may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.