New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - mycophenolate mofetil 200 mg/ml;   - powder for oral suspension - 200 mg/ml - active: mycophenolate mofetil 200 mg/ml   excipient: aspartame citric acid colloidal silicon dioxide fruit mix flavour 274869 lecithin methyl hydroxybenzoate sodium citrate dihydrate sorbitol xanthan gum - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

United States - English - NLM (National Library of Medicine)

novartis vaccines and diagnostics ltd - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) (unii: k9p8pva2ug) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) - unii:k9p8pva2ug) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. influenza a (h1n1) 2009 monovalent vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of influenza a (h1n1) 2009 monovalent vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see description (11)]. novartis’ influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluvirin) are manufactured by the same process. available information for fluvirin is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluvirin. it is also not known whether influenza a (h1n1) 2009 monovalent vaccine or fluvirin can cause fetal harm when administered to

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - danazol 200mg - capsule - 200 mg - active: danazol 200mg excipient: colloidal silicon dioxide erythrosine gelatin   iron oxide red iron oxide yellow lactose lactose monohydrate magnesium stearate microcrystalline cellulose povidone sodium laurilsulfate sodium starch glycolate tekprint black sw-9008 titanium dioxide   - endometriosis: danazol is indicated for use in the treatment of endometriosis amenable to hormonal management. menorrhagia: danazol is indicated for the short-term (up to 6 months) management of primary menorrhagia. fibrocystic disease of the breast: danazol is indicated for the treatment of fibrocystic disease of the breast in both pre- and post-menopausal women. hereditary angioedema: danazol is indicated for the prophylaxis of attacks of hereditary angioedema of a severe or life-threatening nature, in male and female patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - topiramate 200mg;   - film coated tablet - 200 mg - active: topiramate 200mg   excipient: colloidal silicon dioxide croscarmellose sodium opadry ii pink 85g34776 magnesium stearate mannitol microcrystalline cellulose pregelatinised maize starch - topiramate actavis is indicated in adults and children. topiramate actavis tablet range is not suitable for any children weighing less than 25 kg and is not suitable as monotherapy for children or adolescents weighing less than 50 kg. - as monotherapy in patients with newly diagnosed epilepsy - for conversion to monotherapy in patients with epilepsy - as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with lennox-gastaut syndrome.

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

seqirus pty ltd - sea snake antivenom, quantity: 1000 u - injection, concentrated - excipient ingredients: phenol; sodium chloride; water for injections - for the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a sea snake.

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

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 200 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; saccharin sodium; purified talc; magnesium stearate; mannitol; flavour - seaze is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy therapy in newly diagnosed paediatric patients is not recommended.( see pharmacology, clinical trials.)

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - quetiapine fumarate 230.244mg equivalent to 200 mg quetiapine - film coated tablet - 200 mg - active: quetiapine fumarate 230.244mg equivalent to 200 mg quetiapine excipient: calcium hydrogen phosphate dihydrate colloidal silicon dioxide hypromellose lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose opacode black s-1-17823 povidone purified talc sodium starch glycolate titanium dioxide - acute and chronic psychoses, including schizophrenia.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - amisulpride 200mg;  ;  ; amisulpride 200mg - tablet - 200 mg - active: amisulpride 200mg     excipient: hydrated silica lactose monohydrate magnesium stearate methylcellulose potato starch active: amisulpride 200mg excipient: hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

max health limited - voriconazole 200mg - powder for infusion - 200 mg - active: voriconazole 200mg excipient: hydrochloric acid hydroxypropyl-beta-cyclodextrin sodium chloride - voriconazole is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

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

roche products pty ltd - mycophenolate mofetil, quantity: 200 mg/ml - suspension - excipient ingredients: citric acid; xanthan gum; aspartame; methyl hydroxybenzoate; purified water; silicon dioxide; sorbitol; lecithin; sodium citrate dihydrate; flavour - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.