Australia - English - Department of Health (Therapeutic Goods Administration)

hospira australia pty ltd - gemcitabine hydrochloride, quantity: 43.27 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - gemcitabine is indicated for treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelian ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first line therapy. gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - gemcitabine as hydrochloride - powder for solution for infusion - gemcitabine as hydrochloride 1500 mg - gemcitabine - gemcitabine - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locallyadvanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreaticcancer.gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage.breast cancer:gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locallyrecurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.prior chemotherapy should have included an anthracycline unless clinically contraindicated.ovarian cancer:gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelialovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Israel - English - Ministry of Health

abic marketing ltd, israel - gemcitabine as hydrochloride - concentrate for solution for infusion - gemcitabine as hydrochloride 40 mg/ml - gemcitabine - gemcitabine - gemcitabine teva® concentrate is indicated for the palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer.gemcitabine teva® concentrate is indicated for the treatment of patients with bladder cancer at the invasive stage.breast cancer:gemcitabine teva® concentrate in combination with paclitaxel,is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant /neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.ovarian cancer:gemcitabine teva® concentrate in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma who have relapsed at least 6 months after platinum-based therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

hospira australia pty ltd - gemcitabine hydrochloride, quantity: 43.27 mg/ml - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - non-small cell lung cancer, pancreatic cancer, biliary tract cancer, uroepithelial cancer, inoperable or recurrent breast cancer, ovarian cancer progressing after chemotherapy, recurrence or refractory malignant lymphoma

Australia - English - Department of Health (Therapeutic Goods Administration)

hospira australia pty ltd - gemcitabine hydrochloride, quantity: 43.27 mg/ml - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide

Australia - English - Department of Health (Therapeutic Goods Administration)

hetero australia pty ltd - gemcitabine hydrochloride, quantity: 1138 mg - injection, powder for - excipient ingredients: mannitol; sodium acetate trihydrate; sodium hydroxide - gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer.,gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.,gemcitabine, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum? based therapy

Australia - English - Department of Health (Therapeutic Goods Administration)

hetero australia pty ltd - gemcitabine hydrochloride, quantity: 228 mg - injection, powder for - excipient ingredients: sodium acetate trihydrate; sodium hydroxide; mannitol - gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer.,gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.,gemcitabine, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum? based therapy

Australia - English - Department of Health (Therapeutic Goods Administration)

hetero australia pty ltd - gemcitabine hydrochloride, quantity: 1138 mg - injection, powder for - excipient ingredients: mannitol; sodium acetate trihydrate; sodium hydroxide - gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer.,gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.,gemcitabine, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum? based therapy

Australia - English - Department of Health (Therapeutic Goods Administration)

hetero australia pty ltd - gemcitabine hydrochloride, quantity: 228 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide; sodium acetate trihydrate - gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer.,gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.,gemcitabine, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum? based therapy

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - gemcitabine hydrochloride, quantity: 1138.526 mg (equivalent: gemcitabine, qty 1000 mg) - injection, concentrated - excipient ingredients: sodium acetate; hydrochloric acid; sodium hydroxide; water for injections - treatment of patients with locally advanced or metastatic non-small celll lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. treatment of patients with 5-fu refractory pancreatic cancer. treatment of patients with bladder cancer, alone or in combination with cisplatin. treatment, in combinatin with paclitaxel, of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. treatment, in combinatin with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed > six months following platinum based therapy.