Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; miltefosine

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml;   - concentrate for infusion - 4 mg/5ml - active: zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml   excipient: hydrochloric acid sodium citrate sodium hydroxide water for injection - · treatment of tumour-induced hypercalcaemia.

Malta - English - Medicines Authority

hospira uk limited - irinotecan - concentrate for solution for infusion - irinotecan 20 mg - antineoplastic agents

Malta - English - Medicines Authority

hospira uk limited - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - irinotecan hydrochloride trihydrate 20 mg - antineoplastic agents

Malta - English - Medicines Authority

hospira uk limited - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - irinotecan hydrochloride trihydrate 20 mg - antineoplastic agents

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

fresenius kabi australia pty ltd - moxifloxacin hydrochloride, quantity: 1.75 mg/ml - injection, intravenous infusion - excipient ingredients: sodium sulfate; sulfuric acid; sodium acetate trihydrate; water for injections - moxifloxacin kabi intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions:,- community acquired pneumonia (caused by susceptible organisms),- acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics,- moxifloxacin kabi intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents, (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin kabi may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

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

fresenius kabi australia pty ltd - moxifloxacin hydrochloride, quantity: 1.75 mg/ml - injection, intravenous infusion - excipient ingredients: water for injections; sodium acetate trihydrate; sodium sulfate; sulfuric acid - moxifloxacin kabi intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions:,- community acquired pneumonia (caused by susceptible organisms),- acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics,- moxifloxacin kabi intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents, (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin kabi may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

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

accord healthcare pty ltd - zoledronic acid monohydrate, quantity: 4.264 mg (equivalent: zoledronic acid, qty 4 mg) - injection, concentrated - excipient ingredients: sodium citrate dihydrate; mannitol; water for injections - zoledronic acid accord is indicated:,for the prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone.,for treatment of tumour-induced hypercalcaemia.,as an adjunct to adjuvant treatment for women with early breast cancer who are in established menopause.

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

accord healthcare pty ltd - docetaxel, quantity: 80 mg - injection, concentrated - excipient ingredients: polysorbate 80; ethanol absolute; citric acid - breast cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease adjuvant treatment of breast cancer docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2 docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of = 1 cm and < 7 cm. non small cell lung cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based chemotherapy. ovarian cancer docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. prostate cancer docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. head and neck cancer docetaxel in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

accord healthcare pty ltd - docetaxel, quantity: 160 mg - injection, concentrated - excipient ingredients: citric acid; ethanol absolute; polysorbate 80 - breast cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease adjuvant treatment of breast cancer docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2 docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of = 1 cm and < 7 cm. non small cell lung cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based chemotherapy. ovarian cancer docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. prostate cancer docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. head and neck cancer docetaxel in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.