New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - buprenorphine hydrochloride 8.64mg equivalent to 8 mg buprenorphine; naloxone hydrochloride dihydrate 2.44mg equivalent to 2 mg naloxone - sublingual tablet - 8mg/2mg - active: buprenorphine hydrochloride 8.64mg equivalent to 8 mg buprenorphine naloxone hydrochloride dihydrate 2.44mg equivalent to 2 mg naloxone excipient: acesulfame potassium citric acid lactose monohydrate lemon flavour phs-020484 magnesium stearate maize starch mannitol povidone sodium citrate dihydrate - treatment of opiate dependence, within a framework of medical, social and psychological treatment. naloxone is included in suboxone to deter intravenous misuse of the product.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19 f; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 3; pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 9v - suspension for injection - pneumococcal polysaccharide serotype 23f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19 f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 14 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 9v 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 7f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6b 4.4 mcg / 0.5 ml; pneumococcal polysaccharide serotype 5 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 4 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 1 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 3 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6a 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 18c 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19a 2.2 mcg / 0.5 ml - pneumococcus, purified polysaccharides antigen conjugated - pneumococcus, purified polysaccharides antigen conjugated - active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mucopolysaccharidosis ii - other alimentary tract and metabolism products, - elaprase is indicated for the long-term treatment of patients with hunter syndrome (mucopolysaccharidosis ii, mps ii). heterozygous females were not studied in the clinical trials.

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

arrotex pharmaceuticals pty ltd - olmesartan medoxomil, quantity: 20 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: hypromellose; purified water; hyprolose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; titanium dioxide; iron oxide yellow; macrogol 4000 - indicated for the treatment of hypertension.,treatment should not be initiated with this fixed dose combination.

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

arrotex pharmaceuticals pty ltd - olmesartan medoxomil, quantity: 40 mg; hydrochlorothiazide, quantity: 25 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hypromellose; purified water; microcrystalline cellulose; hyprolose; magnesium stearate; titanium dioxide; iron oxide yellow; macrogol 4000 - indicated for the treatment of hypertension.,treatment should not be initiated with this fixed dose combination.

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

arrotex pharmaceuticals pty ltd - hydrochlorothiazide, quantity: 12.5 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; hyprolose; purified water; microcrystalline cellulose; hypromellose; titanium dioxide; iron oxide yellow; macrogol 4000 - indicated for the treatment of hypertension.,treatment should not be initiated with this fixed dose combination.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

strides pharma uk ltd - domperidone maleate - oral tablet - 10mg

Israel - English - Ministry of Health

organon pharma israel ltd., israel - atorvastatin as calcium trihydrate; ezetimibe - film coated tablets - atorvastatin as calcium trihydrate 10 mg; ezetimibe 10 mg - atorvastatin and ezetimibe - - prevention of cardiovascular eventsatozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs), either previously treated with a statin or not.- hypercholesterolaemiaatozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- homozygous familial hypercholesterolaemia (hofh)atozet is indicated as adjunctive therapy to diet for use in adults with hofh. patients may also receive adjunctive treatments (e.g., low-density lipoprotein [ldl] apheresis).

Israel - English - Ministry of Health

organon pharma israel ltd., israel - atorvastatin as calcium trihydrate; ezetimibe - film coated tablets - atorvastatin as calcium trihydrate 20 mg; ezetimibe 10 mg - atorvastatin and ezetimibe - - prevention of cardiovascular eventsatozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs), either previously treated with a statin or not.- hypercholesterolaemiaatozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- homozygous familial hypercholesterolaemia (hofh)atozet is indicated as adjunctive therapy to diet for use in adults with hofh. patients may also receive adjunctive treatments (e.g., low-density lipoprotein [ldl] apheresis).

Israel - English - Ministry of Health

organon pharma israel ltd., israel - atorvastatin as calcium trihydrate; ezetimibe - film coated tablets - atorvastatin as calcium trihydrate 40 mg; ezetimibe 10 mg - atorvastatin and ezetimibe - - prevention of cardiovascular eventsatozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs), either previously treated with a statin or not.- hypercholesterolaemiaatozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- homozygous familial hypercholesterolaemia (hofh)atozet is indicated as adjunctive therapy to diet for use in adults with hofh. patients may also receive adjunctive treatments (e.g., low-density lipoprotein [ldl] apheresis).