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SIMVASTATIN SANDOZ (Sandoz Pty Ltd)
Product name
SIMVASTATIN SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
27 working days (255)
Active ingredients
simvastatin
Registration type
EOI
Indication
Generic medicine
SIMVASTATIN SANDOZ is now also indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial J140hypercholesterolaemia (HeFH).
Prior to initiating therapy with SIMVASTATIN SANDOZ, 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.