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GEMCITABINE EPSL (Eugia Pharma (Australia) Pty Ltd)

Product name
GEMCITABINE EPSL
Sponsor
Eugia Pharma (Australia) Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
136 (255 working days)
Active ingredients
gemcitabine hydrochloride
Registration type
New generic medicine
Indication

[TRADE NAME] Injection is indicated:

  • for treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.
  • for treatment of patients with 5-Fluorouracil refractory pancreatic cancer.
  • alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.
  • in combination with paclitaxel, 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.
  • in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.