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

abbott australasia pty ltd diagnostic division - 48524 - human t-cell lymphotrophic virus 1 & 2 (htlv1 & htlv2) antibody ivd, kit, chemiluminescent immunoassay - a chemiluminescent assay for the qualitative detection of htlv-i and htlv-ii in human clinical specimens. the architect rhtlv-i/ii assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of antibodies to htlv-i and htlv-ii in human serum and plasma including specimens collected post-mortem (non-heart-beating) on the architect analyser. performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.

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

diasorin australia pty ltd - 48366 - hepatitis c virus total antibody ivd, kit, chemiluminescent assay - the liaison? xl murex hcv ab assay uses chemiluminescence immunoassay (clia) technology for the qualitative determination of specific antibodies to hepatitis c virus (anti-hcv) in human serum or plasma samples. the test has to be performed on the liaison? xl analyzers only. for the qualitative determination of specific antibodies to hepatitis c virus (anti-hcv) in human serum or plasma samples. post mortem samples collected up to 24 hours after death have been tested and may be also used in the assay.

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

mp biomedicals australasia pty ltd - 48367 - hepatitis c virus total antibody ivd, kit, immunoblot - the mp diagnostics hcv blot 3.0 western blot kit includes structural and nonstructural antigens from hcv and is intended as supplemental confirmatory assay for presence of antibodies to hcv mp diagnostics hcv blot 3.0 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to hcv in human serum or plasma. it is intended for use as a more specific supplemental test on specimens found repeatedly reactive using specific procedures such as elisa

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

mp biomedicals australasia pty ltd - 48453 - hiv1/hiv2 antibody ivd, kit, immunoblot - the mp diagnostics hiv blot 2.2 kit is a western blot immunoassay kit intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using elisa mp diagnostics hiv blot 2.2 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to human immunodeficiency virus type 1 (hiv-1) and type 2 (hiv-2) in human serum or plasma. it is intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using screening procedures such as the enzyme-linked immunosorbent assay (elisa).

Australia - Inggris - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - antipmsg monoclonal antibody - immunotherapy - cow | bovine | female cattle - not applicable (vet)

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 10 mg/ml (murine/human monoclonal antibody);  ;  ;   - concentrate for infusion - 10 mg/ml - active: rituximab 10 mg/ml (murine/human monoclonal antibody)       excipient: citric acid hydrochloric acid polysorbate 80 sodium chloride sodium citrate dihydrate water for injection - mabthera is indicated for the treatment of patients with: · cd20 positive, previously untreated low-grade or follicular, b-cell non-hodgkin's lymphoma in combination with chemotherapy. · cd20 positive, relapsed or chemoresistant low-grade or follicular, b-cell non-hodgkin's lymphoma. · cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. mabthera is indicated for maintenance treatment of patients with cd20 positive, low grade or follicular, b-cell non-hodgkin's lymphoma.

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - chorionic gonadotrophin 500 [iu] (material -hormone hcg ex netherlands,belgium);   - injection with diluent - 500 iu - active: chorionic gonadotrophin 500 [iu] (material -hormone hcg ex netherlands,belgium)   excipient: gelatin sodium chloride

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - human chorionic gonadotrophin highly purified 5 [iu] (material -hormone hcg ex netherlands,belgium); sodium chloride 9mg - injection with diluent - 5 iu - active: human chorionic gonadotrophin highly purified 5 [iu] (material -hormone hcg ex netherlands,belgium) excipient: gelatin mannitol polysorbate 20 water for injection active: sodium chloride 9mg excipient: water for injection

Singapura - Inggris - HSA (Health Sciences Authority)

merck pte. ltd. - cetuximab, chimeric antibody - infusion, solution - 5mg/ml - cetuximab, chimeric antibody 5mg/ml

Uni Eropa - Inggris - EMA (European Medicines Agency)

merck europe b.v. - choriogonadotropin alfa - anovulation; reproductive techniques, assisted; infertility, female - sex hormones and modulators of the genital system, - ovitrelle is indicated in the treatment of:women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (ivf): ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth;anovulatory or oligo-ovulatory women: ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.