Australien - Englisch - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct946 - general laboratory reagent and consumables ivds - ivds that are general laboratory reagents, products or consumables, that are intended to be used specifically as an ivd in the testing of specimens within a clinical laboratory.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

jiangsu hengrui pharmaceuticals co., ltd. - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [ see clinical studies ( 14.2, 14.3) ]. letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

australia biotech pty ltd - ct946 - general laboratory reagent and consumables ivds - for isolation and purification of high-quality viral dna / rna from serum, plasma, swab preservation solution or various virus preservation solutions. only available for lab on ivd application. during the nucleic acid extraction process, the magnetic bead adsorption principle is used to adsorb, transfer, and purify nucleic acids through special magnetic beads to automatically complete the nucleic acid extraction.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

schiffa health pty ltd - ct945 - general laboratoryware ivds - a device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette or a dispenser and where the required volume of liquid is drawn for delivery to the target receptacle. it may show a gradient scale or not and is usually made of plastic but may also be made of glass. this is a single-use device.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - covid-19 coronavirus real-time pcr kit is an in vitro diagnostic (ivd) reagent replying on fluorescent pcr technology and aiming at qualitatively detect sars-cov-2 novel coronavirus from upper and lower respiratory tract samples. upper respiratory tract samples include throat swab, nasal swab, and nasopharyngeal extract. lower respiratory tract samples include sputum, respiratory tract extract, bronchial perfusate, and bronchoalveolar lavage fluid. sampling objectives include suspected cases infected by sars-cov-2, suspected cases due to crowd gathering, other cases need to be diagnosed with sars-cov-2, and other suspected environmental and biomaterials (for traceability analysis, for example). sampling should be carried out by well-trained professionals with biosafety and experimental skills. typically sars-cov-2 rna could be detected from upper and lower respiratory tract samples if a person is infected. a positive result suggests sars-cov-2 infection but bacteria and other virus-induced co-infection could not be excluded. sars-cov-2 test result is not the only confirmed evidence of suspected cases and all positive results have to be reported to the centers for disease control (cdcs) and authorities. negative results can neither straightforwardly exclude sars-cov-2 infection and nor the only decision-making evidence for treatment and patient management. a negative result should be appropriately used by combining clinical observation, medical history, and epidemiological information. the test is only available to qualified laboratories, certificated clinical pcr laboratories and 15189 certified third-party laboratories with real-time pcr thermal cyclers. operators carrying out sars-cov-2 nucleic acid testing should be well trained with laboratory biosafety and pcr experimental skills.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

ivf gen (australia) - ct945 - general laboratoryware ivds - lab consumables/disposable products used for testing, analysis and evaluation of human gametes (sperms & oocytes) and human embryos in ivf laboratory. individual products are as below: (1) centrifuge tubes (2) culture tubes (3) petri dishes (4) serological pipettes (5) transfer pipettes (6) cryo vials

Neuseeland - Englisch - Ministry for Primary Industries

jiangsu good harvest weien agrochemical co. ltd - glyphosate - glyphosate 700 g/kg - herbicide

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

jiangsu hansoh pharmaceutical group co., ltd. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine tablets is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [ see clinical studies ( 14.1)]. when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions ( 5.5 )]. oral olanzapine tablets is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patie

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

well biotech pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - intended to detect the novel coronavirus sars-cov-2 that causes covid-19. for self-testing by lay persons (saliva).

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

lry group of companies pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - intended to detect the novel coronavirus sars-cov-2 that causes covid-19 from symptomatic individuals for self-testing by lay persons (saliva).