Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - fimasartan potassium trihydrate -

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - tigecycline - powder for solution for infusion - tigecycline 50 mg/dose - tigecycline - tygacil is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below for patients 18 years of age and older:complicated skin and skin structure infections:complicated skin and skin structure infections caused by escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates ), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus), streptococcus pyogenes, enterobacter cloacae, klebsiella pneumoniae, and bacteroides fragilis .complicated intra-abdominal infections:complicated intra-abdominal infections caused by citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. angino

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 12.30 mg/dose - dapagliflozin - forxiga is indicated:- in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise •as monotherapy when metformin is considered inappropriate due to intolerance. •in addition to other medicinal products for the treatment of type 2 diabetes. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (nyha class ii-iv) with reduced ejection fraction- to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. limitations of use -forxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. forxiga is not expected to be effective in these populations.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 6.150 mg/dose - dapagliflozin - forxiga is indicated:- in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise •as monotherapy when metformin is considered inappropriate due to intolerance. •in addition to other medicinal products for the treatment of type 2 diabetes. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (nyha class ii-iv) with reduced ejection fraction- to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. limitations of use -forxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. forxiga is not expected to be effective in these populations.

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

bristol-myers squibb australia pty ltd - dapagliflozin propanediol monohydrate -

New Zealand - English - Medsafe (Medicines Safety Authority)

organon (new zealand) limited - etoricoxib 120mg; etoricoxib 120mg - film coated tablet - 120 mg - active: etoricoxib 120mg excipient: calcium hydrogen phosphate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry green 39k11529 purified water active: etoricoxib 120mg excipient: calcium hydrogen phosphate dihydrate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry green 39k11529 purified water - arcoxia is indicated for: · acute and chronic treatment of the signs and symptoms of osteoarthritis (oa) and rheumatoid arthritis (ra) · the management of ankylosing spondylitis (as) · treatment of acute gouty arthritis · relief of acute pain, including pain related to minor dental procedures · relief of chronic musculoskeletal pain the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapy i.e.paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and · after assessment of the individual patient's overall risk factors for developing severe adverse events e.g. history of cardiovascular, renal or gastrointestinal disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

organon (new zealand) limited - etoricoxib 30mg - film coated tablet - 30 mg - active: etoricoxib 30mg excipient: calcium hydrogen phosphate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry green 39k11526 purified water - arcoxia is indicated for: · acute and chronic treatment of the signs and symptoms of osteoarthritis (oa) and rheumatoid arthritis (ra) · the management of ankylosing spondylitis (as) · treatment of acute gouty arthritis · relief of acute pain, including pain related to minor dental procedures · relief of chronic musculoskeletal pain the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapy i.e.paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and · after assessment of the individual patient's overall risk factors for developing severe adverse events e.g. history of cardiovascular, renal or gastrointestinal disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

organon (new zealand) limited - etoricoxib 60mg; etoricoxib 60mg - film coated tablet - 60 mg - active: etoricoxib 60mg excipient: calcium hydrogen phosphate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry green 39k11520 purified water active: etoricoxib 60mg excipient: calcium hydrogen phosphate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry green 39k11520 purified water - arcoxia is indicated for: · acute and chronic treatment of the signs and symptoms of osteoarthritis (oa) and rheumatoid arthritis (ra) · the management of ankylosing spondylitis (as) · treatment of acute gouty arthritis · relief of acute pain, including pain related to minor dental procedures · relief of chronic musculoskeletal pain the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapy i.e.paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and · after assessment of the individual patient's overall risk factors for developing severe adverse events e.g. history of cardiovascular, renal or gastrointestinal disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

organon (new zealand) limited - etoricoxib 90mg; etoricoxib 90mg - film coated tablet - 90 mg - active: etoricoxib 90mg excipient: calcium hydrogen phosphate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry white 39k18305 purified water active: etoricoxib 90mg excipient: calcium hydrogen phosphate dihydrate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry white 39k18305 purified water - arcoxia is indicated for: · acute and chronic treatment of the signs and symptoms of osteoarthritis (oa) and rheumatoid arthritis (ra) · the management of ankylosing spondylitis (as) · treatment of acute gouty arthritis · relief of acute pain, including pain related to minor dental procedures · relief of chronic musculoskeletal pain the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapy i.e.paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and · after assessment of the individual patient's overall risk factors for developing severe adverse events e.g. history of cardiovascular, renal or gastrointestinal disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg;   - film coated tablet - 10 mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg   excipient: colloidal silicon dioxide crospovidone opadry ii yellow lactose magnesium stearate microcrystalline cellulose - monotherapy forxiga is indicated in adults with type 2 diabetes mellitus as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated. initial combination forxiga is indicated in adults with type 2 diabetes mellitus as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy. add-on combination forxiga is indicated in adult patients with type 2 diabetes mellitus in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise do not provide adequate glycaemic control. prevention of hospitalisation for heart failure forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart. prevention of new or worsening nephropathy forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy.