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

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 21.7 mg (equivalent: atorvastatin, qty 20 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; sodium lauryl sulfate; silicon dioxide; povidone; magnesium stearate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials). primary hypercholesterolaemia atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

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

sanofi-aventis australia pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hydrogenated castor oil; carnauba wax; microcrystalline cellulose; macrogol 6000; hyprolose; mannitol; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red - prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. acute coronary syndrome: iscover is indicated in combination with aspirin for patients with: unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). iscover is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or pci, with or without stent); st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, iscover has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

alphapharm pty ltd - clopidogrel hydrogen sulfate, quantity: 97.9 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; lactose; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; titanium dioxide; hypromellose; macrogol 8000; polydextrose; macrogol 400 - prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. acute coronary syndrome: piax is indicated in combination with aspirin for patients with:- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). piax is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or pci, with or without stent). -st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, piax has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

alphapharm pty ltd - clopidogrel hydrogen sulfate, quantity: 97.9 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: lactose; magnesium stearate; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; sodium lauryl sulfate; macrogol 8000; hypromellose; macrogol 400; titanium dioxide; polydextrose - prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. acute coronary syndrome: piax is indicated in combination with aspirin for patients with:- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). piax is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or pci, with or without stent). -st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, piax has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

sanofi-aventis australia pty ltd - clopidogrel hydrogen sulfate, quantity: 391.5 mg (equivalent: clopidogrel, qty 300 mg) - tablet, film coated - excipient ingredients: hydrogenated castor oil; hyprolose; microcrystalline cellulose; mannitol; macrogol 6000; carnauba wax; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red - prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. acute coronary syndrome. plavix is indicated in combination with aspirin for patients with: unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). plavix is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or pci, with or without stent). st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, plavix has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

sanofi-aventis australia pty ltd - alirocumab, quantity: 300 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

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

zoetis australia pty ltd - feline calicivirus - inactivated; feline leukaemia virus - inactivated; feline chlamydia psittaci - inactivated; feline panleucopenia virus - inactivated; feline rhinotracheitis virus - inactivated - misc. vaccines or anti sera - feline calicivirus - inactivated vaccine-viral active 0.0 u; feline leukaemia virus - inactivated vaccine-viral active 0.0 u; feline chlamydia psittaci - inactivated vaccine-viral active 0.0 u; feline panleucopenia virus - inactivated vaccine-viral active 0.0 u; feline rhinotracheitis virus - inactivated vaccine-viral active 0.0 u - immunotherapy - cat - over 8 weeks of age - feline calicivirus | feline chlamydia psittaci | feline enteritis | feline leukaemia virus | feline rhinotracheitis | calicivirus (feline) | disease caused by | enteritis (feline) | fcv | feline herpesvirus type 1 | feline infectious enteritis | feline panleucopenia (fp) | fhv-1 | fvr | herpesvirus 1 (feline) | herpesvirus type 1 (feline) | panleucopenia (feline) | rhinotracheitis (feline)

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

boehringer ingelheim animal health australia pty. ltd. - feline calicivirus - inactivated; chlamydophilia felis inactivated; feline leukaemia virus - inactivated; feline panleucopenia virus - inactivated; feline rhinotracheitis virus - inactivated; amphotericin; neomycin; polymyxin b; thiomersal - misc. vaccines or anti sera - feline calicivirus - inactivated vaccine-viral active 0.0 p; chlamydophilia felis inactivated vaccine-viral active 0.0 p; feline leukaemia virus - inactivated vaccine-viral active 0.0 p; feline panleucopenia virus - inactivated vaccine-viral active 0.0 p; feline rhinotracheitis virus - inactivated vaccine-viral active 0.0 p; amphotericin antibiotic other 0.32 ug/ml; neomycin antibiotic other 4.0 ug/ml; polymyxin b antibiotic other 14.0 iu/ml; thiomersal mercury other 18.0 ug/ml - immunotherapy - cat - over 8 weeks of age - feline calicivirus | feline chlamydia psittaci | feline enteritis | feline leukaemia virus | feline rhinotracheitis | calicivirus (feline) | disease caused by | enteritis (feline) | fcv | feline herpesvirus type 1 | feline infectious enteritis | feline panleucopenia (fp) | fhv-1 | fvr | herpesvirus 1 (feline) | herpesvirus type 1 (feline) | panleucopenia (feline) | rhinotracheitis (feline)

Den europeiske union - engelsk - EMA (European Medicines Agency)

zoetis belgium sa  - inactivated feline rhinotracheitis virus, inactivated feline calicivirus, inactivated feline chlamydophila felis, inactivated feline leukaemia virus, inactivated feline panleukopenia virus - immunologicals - cats - for the active immunisation of healthy cats nine weeks or older against feline panleukopenia and feline leukaemia viruses and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and chlamydophila felis.

Den europeiske union - engelsk - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - feline leukaemia virus recombinant canarypox virus (vcp97) - immunologicals for felidae, - cats - active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.onset of immunity has been demonstrated 2 weeks after primary vaccination course.the duration of immunity is one year after the last vaccination.