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

recombinant) solution for injection 0.5ml pre-filled syringes (imported (united states) - recombinant haemagglutinin proteins - solution for injection

Canada - English - Health Canada

aa pharma inc - lansoprazole; amoxicillin; clarithromycin - capsule (delayed release) - 30mg; 500mg; 500mg - lansoprazole 30mg; amoxicillin 500mg; clarithromycin 500mg - other macrolides

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

organon pharma pty ltd - ethinylestradiol, quantity: 2.7 mg; etonogestrel, quantity: 11.7 mg - drug delivery system, vaginal - excipient ingredients: magnesium stearate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; isododecane; ethylene/vinyl acetate copolymer; ethylene distearamide - nuvaring is for use for contraception.

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

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.32 mg (equivalent: estradiol, qty 2.25 mg) - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; isopropyl palmitate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

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

organon pharma pty ltd - ethinylestradiol, quantity: 2.7 mg; etonogestrel, quantity: 11.7 mg - drug delivery system, vaginal - excipient ingredients: magnesium stearate; vinyl acetate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; isododecane; ethylene/vinyl acetate copolymer - nuvaring is for use for contraception.

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

bayer australia ltd - levonorgestrel, quantity: 19.5 mg - drug delivery system, intrauterine - excipient ingredients: dimethylsiloxane/methylvinylsiloxane cross linked elastomer - contraception for up to 5 years

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

sandoz pty ltd - buprenorphine, quantity: 5 mg - drug delivery system, transdermal - excipient ingredients: levulinic acid; oleyl oleate; povidone; polyethylene; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz 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. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.

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

sandoz pty ltd - buprenorphine, quantity: 20 mg - drug delivery system, transdermal - excipient ingredients: povidone; oleyl oleate; polyethylene; levulinic acid; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz 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. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.

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

sandoz pty ltd - buprenorphine, quantity: 15 mg - drug delivery system, transdermal - excipient ingredients: povidone; polyethylene; levulinic acid; oleyl oleate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz 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. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.

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

sandoz pty ltd - buprenorphine, quantity: 10 mg - drug delivery system, transdermal - excipient ingredients: povidone; polyethylene; levulinic acid; oleyl oleate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz 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. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.