Israel - English - Ministry of Health

rafa laboratories ltd - fluticasone propionate; formoterol fumarate dihydrate - pressurised suspention for inhalation - fluticasone propionate 0.05 mg/dose; formoterol fumarate dihydrate 0.005 mg/dose - fluticasone - fluticasone - the regular treatment of asthma where use of a combination product (an inhaled corticosteroid and a long -acting β2 agonist) is appropriate:• for patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short -acting β2 agonist.• for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.flutiform 50mcg/5mcg inhaler is indicated in adults, adolescents and children aged 5 years and above.

Israel - English - Ministry of Health

rafa laboratories ltd - fluticasone propionate; formoterol fumarate dihydrate - pressurised suspention for inhalation - fluticasone propionate 0.125 mg/dose; formoterol fumarate dihydrate 0.005 mg/dose - fluticasone - fluticasone - the regular treatment of asthma where use of a combination product (an inhaled corticosteroid and a long -acting β2 agonist) is appropriate:• for patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short -acting β2 agonist.• for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.flutiform 125mcg/5mcg inhaler is indicated in adults and adolescents aged 12 years and above.

Israel - English - Ministry of Health

rafa laboratories ltd - fluticasone propionate; formoterol fumarate dihydrate - pressurised suspention for inhalation - fluticasone propionate 0.25 mg/dose; formoterol fumarate dihydrate 0.01 mg/dose - fluticasone - fluticasone - the regular treatment of asthma where use of a combination product (an inhaled corticosteroid and a long -acting β2 agonist) is appropriate:• for patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short -acting β2 agonist.• for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.flutiform 250mcg/10mcg inhaler is indicated in adults only.

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

mundipharma pty ltd - fluticasone propionate, quantity: 40.1 mg; formoterol fumarate dihydrate, quantity: 1.6 mg - inhalation, pressurised - excipient ingredients: ethanol absolute; sodium cromoglycate; apaflurane - flutiform inhaler is indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting beta2-agonist) is appropriate. this includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonist on an ?as required? basis.

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

mundipharma pty ltd - fluticasone propionate, quantity: 20 mg; formoterol fumarate dihydrate, quantity: 0.801 mg - inhalation, pressurised - excipient ingredients: sodium cromoglycate; ethanol absolute; apaflurane - flutiform inhaler is indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting beta2-agonist) is appropriate. this includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonist on an ?as required? basis.

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

mundipharma pty ltd - formoterol fumarate dihydrate, quantity: 0.801 mg; fluticasone propionate, quantity: 8.01 mg - inhalation, pressurised - excipient ingredients: ethanol absolute; sodium cromoglycate; apaflurane - flutiform inhaler is indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting beta2-agonist) is appropriate. this includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonist on an ?as required? basis.

Ireland - English - HPRA (Health Products Regulatory Authority)

mundipharma pharmaceuticals limited - fluticasone propionate; formoterol fumarate dihydrate - pressurised inhalation, suspension - 125 µg/5 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and fluticasone

Ireland - English - HPRA (Health Products Regulatory Authority)

mundipharma pharmaceuticals limited - fluticasone propionate; formoterol fumarate dihydrate - pressurised inhalation, suspension - 50 µg/5 µg/actuation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and fluticasone

Ireland - English - HPRA (Health Products Regulatory Authority)

mundipharma pharmaceuticals limited - fluticasone propionate; formoterol fumarate dihydrate - pressurised inhalation, suspension - 250 µg/10 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and fluticasone

Ireland - English - HPRA (Health Products Regulatory Authority)

mundipharma pharmaceuticals limited - fluticasone propionate; formoterol fumarate dihydrate - pressurised inhalation, suspension - 50 µg/5 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and fluticasone