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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
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.
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.