New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - simvastatin 80mg;  ;   - film coated tablet - 80 mg - active: simvastatin 80mg     excipient: ascorbic acid butylated hydroxytoluene citric acid monohydrate colloidal silicon dioxide hypromellose iron oxide red isopropyl alcohol lactose monohydrate macrogol 400 magnesium stearate maize starch microcrystalline cellulose purified talc purified water   sodium starch glycolate starch titanium dioxide - patients at high risk of coronary heart disease (chd) or with existing chd. in patients at high risk of chd (with or without hyperlipidaemia but with a total cholesterol >3.5mmol/l), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, simvastatin is indicated to: · reduce the risk of total mortality by reducing chd deaths · reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, chd death, stroke, or revascularisation procedures · reduce the risk of major coronary events (a composite of non-fatal myocardial infarction or chd deaths) · reduce the risk of stroke · reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty) · reduce the need for peripheral and other non-coronary revascularisation procedures · reduce the risk of hospitalisation for angina pectoris in patients with diabetes, simvastatin reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations or leg ulcers). in hypercholesterolaemic patients with coronary heart disease, simvastatin slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - miglustat 100mg - capsule - 100 mg - active: miglustat 100mg excipient: gelatin magnesium stearate povidone sodium starch glycolate titanium dioxide - zavesca® is indicated for the treatment of progressive neurological manifestations in adult and paediatric patients with niemann-pick type c disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - ticagrelor 60mg;  ;  ;   - film coated tablet - 60 mg - active: ticagrelor 60mg       excipient: calcium hydrogen phosphate hyprolose hypromellose iron oxide black iron oxide red macrogol 400 magnesium stearate mannitol purified water   sodium starch glycolate titanium dioxide - brilinta, co-administered with acetylsalicylic acid (aspirin), is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) · in patients with acute coronary syndromes (unstable angina [ua], non st elevation myocardial infarction [nstemi] or st elevation myocardial infarction [stemi]); including patients managed medically, and those who are managed with percutaneous coronary intervention (pci) or coronary artery by-pass grafting (cabg). · in patients with a history of myocardial infarction (mi occurred at least one year ago) and a high risk of developing an atherothrombotic event.

New Zealand - English - Medsafe (Medicines Safety Authority)

orion pharma (nz) limited - buspirone hydrochloride 10mg - tablet - 10 mg - active: buspirone hydrochloride 10mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - buspirone hydrochloride is indicated for the management of anxiety with or without accompanying depression in adults. buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression.

New Zealand - English - Medsafe (Medicines Safety Authority)

orion pharma (nz) limited - buspirone hydrochloride 5mg - tablet - 5 mg - active: buspirone hydrochloride 5mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - buspirone hydrochloride is indicated for the management of anxiety with or without accompanying depression in adults. buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 400mg; darunavir 400mg - film coated tablet - 400 mg - active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f530014 sodium starch glycolate active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir mylan (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients. darunavir mylan (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 600mg; darunavir 600mg - film coated tablet - 600 mg - active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f93050 sodium starch glycolate active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir mylan (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients. darunavir mylan (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.

New Zealand - English - Medsafe (Medicines Safety Authority)

psm healthcare ltd trading as api consumer brands - finasteride 1mg - film coated tablet - 1 mg - active: finasteride 1mg excipient: docusate sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry brown 03a86790 pregelatinised maize starch purified water sodium starch glycolate - pharmacare finasteride 1 mg film coated tablets: finasteride is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. finasteride is not indicated for use in women (see warnings and precautions, pregnancy) or children. finasteride is not effective in postmenopausal women with androgenetic alopecia.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - hyoscine butylbromide 20mg;  ;  ;   - film coated tablet - 20 mg - active: hyoscine butylbromide 20mg       excipient: colloidal silicon dioxide hypromellose lactose monohydrate macrogol 6000 magnesium stearate maize starch methylcellulose microcrystalline cellulose purified talc purified water sodium starch glycolate titanium dioxide - for the relief of stomach ache and pain due to cramps or spasm.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - macitentan 10mg;  ;   - film coated tablet - 10 mg - active: macitentan 10mg     excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opadry white oy-b-28920 amb polysorbate 80 povidone sodium starch glycolate - opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii, iii, or iv. efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease.