GENRX TAMOXIFEN, TAMOXIFEN AJS, TAMOXIFEN SCP (Southern Cross Pharma Pty Ltd)
Product name
GENRX TAMOXIFEN, TAMOXIFEN AJS, TAMOXIFEN SCP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
210 working days (255)
Active ingredients
tamoxifen citrate
Registration type
New generic medicine
Indication
Treatment of breast cancer
GENRX TAMOXIFEN, TAMOXIFEN AJS, TAMOXIFEN SCP (tablets) are indicated for the treatment of breast cancer.
Primary reduction of breast cancer risk
GENRX TAMOXIFEN, TAMOXIFEN AJS, TAMOXIFEN SCP are indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).