Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastic agents - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy.brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

esl biosciences australia 2012 pty ltd - ct353 - bacterial infectious disease ivds - ivds that are intended to be used to determine (qualitative and or quantitative) information about infection with or exposure to one or a number of bacterial diseases in a clinical specimen. each ivd is intended to be used by a medical laboratory scientist. techniques used include: elisa, indirect immunofluorescence,immune blots or western blot

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - ct353 - bacterial infectious disease ivds - for in vitro diagnostic use in testing clinical specimens to provide information about infection with or exposure to one or a number of bacterial diseases

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

becton dickinson pty ltd - ct353 - bacterial infectious disease ivds - in vitro diagnostic tests intended to be used for qualitative detection vancomycin -resistant (vana and vanb) genes, clostridium difficile toxin b genes (cdtb) and/or a number of bacterial infectious agents.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - ct353 - bacterial infectious disease ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to one or a number of bacterial diseases.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

diasorin australia pty ltd - ct353 - bacterial infectious disease ivds - immunoassay based ivd's for the detection of antibodies, antigens and toxins to bacterial infectious diseases in human samples.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

diasorin australia pty ltd - ct353 - bacterial infectious disease ivds - for the in vitro qualitative detection of bacteria present in samples from human individuals suspected of a bacterial infection. for use on the integrated cycler instrument.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

bio-rad laboratories pty ltd - ct353 - bacterial infectious disease ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to one or a number of bacterial diseases.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - ct353 - bacterial infectious disease ivds - for in vitro diagnostic use in testing to provide information about infection with or exposure to one or a number of bacterial diseases.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - ct353 - bacterial infectious disease ivds - qualitative in vitro diagnostic tests for the detection of bacterial organisms in human samples intended to provide information about infection with, or exposure to, one or a number of bacterial diseases. these devices are intended for use in hospital, reference or state laboratory settings. these devices are not intended for point of care use.