Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
ATOMED; ATORSTAT; ATORVASTATIN MLPL; TORMED (Micro Labs Pty Ltd)
Product name
ATOMED; ATORSTAT; ATORVASTATIN MLPL; TORMED
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
146 (255 working days)
Active ingredients
atorvastatin calcium trihydrate
Registration type
New generic medicine
Indication
ATOMED; ATORSTAT; ATORVASTATIN MLPL; TORMED (film-coated tablet) is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.
Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.
Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see section 5.1, Pharmacodynamic properties, clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction (MI) and non-fatal stroke.
These effects do not replace the need to independently control known causes of cardiovascular (CV) mortality and morbidity such as hypertension, diabetes and smoking.