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

gm pharma international pty ltd - ivabradine hydrochloride, quantity: 5.39 mg (equivalent: ivabradine, qty 5 mg) - tablet, film coated - excipient ingredients: maltodextrin; lactose monohydrate; colloidal anhydrous silica; maize starch; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, or in combination with atenolol 50mg once daily when angina is inadequately controlled.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

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

gm pharma international pty ltd - ivabradine hydrochloride, quantity: 8.085 mg (equivalent: ivabradine, qty 7.5 mg) - tablet, film coated - excipient ingredients: maltodextrin; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; maize starch; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000 - treatment of chronic stable angina symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, or in combination with atenolol 50mg once daily when angina is inadequately controlled.,treatment of chronic heart failure treatment of symptomatic chronic heart failure of nyha classes ii or iii and with documented left ventricular ejection fraction (lvef) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ivabradine - film-coated tablet - 5 milligram(s) - other cardiac preparations; ivabradine

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ivabradine - film-coated tablet - 7.5 milligram(s) - other cardiac preparations; ivabradine

Israel - English - Ministry of Health

medison pharma ltd - ivabradine as hydrochloride - film coated tablets - ivabradine as hydrochloride 7.5 mg - ivabradine - ivabradine - symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.treatment of chronic heart failureivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Israel - English - Ministry of Health

medison pharma ltd - ivabradine as hydrochloride - film coated tablets - ivabradine as hydrochloride 5 mg - ivabradine - ivabradine - symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.treatment of chronic heart failureivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

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

mundipharma pty ltd - buprenorphine, quantity: 40 mg - drug delivery system, transdermal - excipient ingredients: levulinic acid; oleyl oleate; povidone; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; heptane; aluminium acetylacetonate - bupredermal patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. bupredermal patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. bupredermal patches are not indicated as an as-needed (prn) analgesia.

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

mundipharma pty ltd - buprenorphine, quantity: 30 mg - drug delivery system, transdermal - excipient ingredients: levulinic acid; oleyl oleate; povidone; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; heptane; aluminium acetylacetonate - bupredermal patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. bupredermal patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. bupredermal patches are not indicated as an as-needed (prn) analgesia.

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

mundipharma pty ltd - buprenorphine, quantity: 25 mg - drug delivery system, transdermal - excipient ingredients: levulinic acid; oleyl oleate; povidone; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; heptane; aluminium acetylacetonate - bupredermal patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. bupredermal patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. bupredermal patches are not indicated as an as-needed (prn) analgesia.

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

mundipharma pty ltd - buprenorphine, quantity: 20 mg - drug delivery system, transdermal - excipient ingredients: oleyl oleate; povidone; levulinic acid; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane - bupredermal patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. bupredermal patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. bupredermal patches are not indicated as an as-needed (prn) analgesia.