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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: histidine hydrochloride; histidine; polysorbate 20; trehalose dihydrate - early breast cancer herzuma? is indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer herzuma? is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herzuma?.,metastatic breast cancer herzuma? is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormonereceptor positive metastatic breast cancer.,advanced gastric cancer herzuma? is indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastro- oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a); influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a); influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) - suspension for injection - 9 mcg - active: influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a) influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a) influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate potassium chloride sodium chloride sodium hydroxide water for injection - intanza 9mcg is indicated for prophylaxis of influenza in adults from 18 to 59 years of age. the use of intanza 9mcg in new zealand should be based on the ministry of health recommendations for influenza vaccination as published in the current new zealand immunisation handbook.

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

alexion pharmaceuticals australasia pty ltd - sebelipase alfa, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; albumin - kanuma (sebelipase alfa rce) is indicated for long-term enzyme replacement therapy (ert) in patients of all ages with lysosomal acid lipase deficiency (lal-d).

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

baxter healthcare pty ltd - soya oil, quantity: 6 g/l; olive oil, quantity: 24 g/l - injection, intravenous infusion - excipient ingredients: nitrogen; water for injections; sodium hydroxide; egg lecithin; sodium oleate; glycerol - olimel/periolimel is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenia purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, guillian barre syndrome. allogenic bone marrow transplantation.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: human immunoglobulin a; sorbitol; water for injections - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenia purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, guillian barre syndrome. allogenic bone marrow transplantation.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenia purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, guillian barre syndrome. allogenic bone marrow transplantation.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: human immunoglobulin a; sorbitol; water for injections - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenia purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, guillian barre syndrome. allogenic bone marrow transplantation.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenia purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, guillian barre syndrome. allogenic bone marrow transplantation.