Canada - English - Health Canada

bayer inc - gadoxetate disodium - solution - 181.43mg - gadoxetate disodium 181.43mg - other diagnostic agents

Canada - English - Health Canada

bayer inc - gadobutrol - solution - 604.72mg - gadobutrol 604.72mg - other diagnostic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - gadobutrol - solution for injection - 1.0 millimole(s)/millilitre - paramagnetic contrast media; gadobutrol

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - gadobutrol - solution for injection in pre-filled syringe - 1.0 millimole(s)/millilitre - paramagnetic contrast media; gadobutrol

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - gadobutrol - solution for injection - 1.0 millimole(s)/millilitre - paramagnetic contrast media; gadobutrol

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

bayer australia ltd - disodium gadoxetate -

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - gadoxetate disodium 181.43 mg/ml (manufactured in-situ from gadolinium oxide and ethoxybenzyl dtpa) - solution for injection - 181.43 mg/ml - active: gadoxetate disodium 181.43 mg/ml (manufactured in-situ from gadolinium oxide and ethoxybenzyl dtpa) excipient: hydrochloric acid as 3.6% w/w aqueous solution caloxetate complexing agent sodium hydroxide trometamol water for injection - for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesions

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - gadobutrol - solution for injection in cartridge - 1.0 millimole(s)/millilitre - paramagnetic contrast media; gadobutrol

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

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: water for injections; trisodium caloxetate; trometamol; hydrochloric acid; sodium hydroxide - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion

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

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: trometamol; sodium hydroxide; hydrochloric acid; water for injections; trisodium caloxetate - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion