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MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX (Medreich Australia Pty Ltd)

Product name
MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX
Sponsor
Medreich Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
143 (255 working days)
Active ingredients
rosuvastatin (as calcium)
Registration type
New generic medicine
Indication

MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX (film-coated tablet) should be used as an adjunct to diet when the response to diet and exercise is inadequate.

Prevention of cardiovascular events

MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX is indicated for prevention of major cardiovascular events in men ≥50 years old and women ≥60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX is indicated to:

  • Reduce the risk of nonfatal myocardial infarction
  • Reduce the risk of nonfatal stroke
  • Reduce the risk of coronary artery revascularisation procedures.
In patients with hypercholesterolaemia

MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).

Prior to initiating therapy with MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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