ZOLADEX(GOSERELIN) LA DEPOT 10.8MG INJECTION

(i) Treatment of prostate cancer in the following settings (see also section 5.1):

• In the treatment of metastatic prostate cancer where Zoladex has demonstrated comparable survival benefits to surgical castrations.
• In the treatment of locally advanced prostate cancer, as an alternative to surgical castration where Zoladex has demonstrated comparable survival benefits to an anti-androgen.
• As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where Zoladex has demonstrated improved disease-free survival and overall survival.
• As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where Zoladex has demonstrated improved disease-free survival.
• As adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression where Zoladex has demonstrated improved disease-free survival.

(ii) ZOLADEX LA 10.8 mg is indicated in the management of oestrogen-receptor (ER) positive early and advanced breast cancer in pre and peri menopausal women.