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

qiagen pty ltd - ct929 - acquired genetic alteration ivds - the ipsogen jak2 rgq pcr kit is a quantitative in vitro pcr assay intended for the detection and quantitation of the jak2 v617f/g1849t mutation in genomic dna extracted from human peripheral whole blood anticoagulated with 2k-edta. results obtained with the ipsogen jak2 rgq pcr kit are intended for use as an adjunct to evaluation of suspected philadelphia (ph) chromosome negative myeloproliferative neoplasm (mpn) and molecular disease monitoring in mpn patients. any diagnostic results generated must be interpreted in conjunction with other clinical-pathological findings. the ipsogen jak2 rgq pcr kit is intended to be used only with the qiagen rotor-gene q mdx 5plex hrm instrument and other validated workflow components as outlined in the instructions for use. the ipsogen jak2 rgq pcr kit is not an automated device, however, the analysis is assisted by a dedicated software. the ipsogen jak2 rgq pcr kit is intended for in vitro diagnostic use.

Israel - English - Ministry of Health

novartis israel ltd - nilotinib as monohydrate - capsules - nilotinib as monohydrate 200 mg - nilotinib - nilotinib - treatment of philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) in chronic or accelerated phase in patients resistant to or experiencing significant toxicity during treatment with imatinib.treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

European Union - English - EMA (European Medicines Agency)

ceva santé animale - genetically modified recombinant shiga-toxin-2e antigen - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - pigs - active immunisation of piglets from the age of four days, to reduce the mortality and clinical signs of oedema disease caused by shiga toxin 2e produced by escherichia coli (stec). onset of immunity: 21 days after vaccination. duration of immunity: 105 days after vaccination.,

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

southern cross diagnostics pty ltd - ct918 - pharmacogenetic ivds - for the simultaneous in vitro qualitative detection of gene mutations in dna to aid in the diagnosis of pharmacogenetic related toxicity in patients referred for drug therapy.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

africa biosystems tanzania ltd, tanzania - genetic analyzer -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

africa biosystems tanzania ltd, tanzania - genetic analyzer -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

africa biosystems tanzania ltd, tanzania - genetic analyzer -

Israel - English - Ministry of Health

novartis israel ltd - nilotinib as hydrochloride monohydrate - capsules - nilotinib as hydrochloride monohydrate 150 mg - nilotinib - nilotinib - treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastic agents - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. , the effect of glivec on the outcome of bone-marrow transplantation has not been determined. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatment;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and / or metastatic dfsp who are not eligible for surgery. , in adult and paediatric patients, the effectiveness of glivec is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds / mpd, on haematological response rates in hes / cel and on objective response rates in adult patients with unresectable and / or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with glivec in patients with mds / mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

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

myriad genetics pty ltd - ct929 - acquired genetic alteration ivds - an in vitro diagnostic kit for patients with estrogen-receptor-positive, her-2 negative primary breast cancer to determine the risk of distant recurrence and to estimate the adjuvant chemotherapy benefit.