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

leo pharma pty ltd - ingenol mebutate -

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

leo pharma pty ltd - ingenol mebutate -

United States - English - NLM (National Library of Medicine)

leo pharma inc. - ingenol mebutate (unii: 7686s50jah) (ingenol mebutate - unii:7686s50jah) - ingenol mebutate 150 ug in 1 g - picato® gel is indicated for the topical treatment of actinic keratosis. picato gel is contraindicated in patients with known hypersensitivity to ingenol mebutate or any component of the formulation. anaphylaxis, as well as allergic reactions leading to hospitalization have been reported in postmarketing use with picato gel [see warnings and precautions (5.2)] . risk summary there are no available data on picato gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. systemic concentrations following topical administration of picato gel were below the limit of quantification of 0.1 ng/ml, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)] . in animal reproduction studies, ingenol mebutate did not cause malformations in pregnant rats and rabbits when given by the intravenous route of administration during the period of organogenesis (see data) . the available data do not

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

alphapharm pty ltd - tamoxifen citrate, quantity: 30.4 mg (equivalent: tamoxifen, qty 20 mg) - tablet, uncoated - excipient ingredients: magnesium stearate; croscarmellose sodium; maize starch; mannitol - treatment of breast cancer. genox is indicated for the treatment of breast cancer. primary reduction of breast cancer risk. genox is indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

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

alphapharm pty ltd - tamoxifen citrate, quantity: 15.2 mg (equivalent: tamoxifen, qty 10 mg) - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; croscarmellose sodium; mannitol - treatment of breast cancer. genox is indicated for the treatment of breast cancer. primary reduction of breast cancer risk. genox is indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

Canada - English - Health Canada

leo pharma inc - ingenol mebutate - gel - 0.015% - ingenol mebutate 0.015% - misc. skin and mucous membrane agents

Canada - English - Health Canada

leo pharma inc - ingenol mebutate - gel - 0.05% - ingenol mebutate 0.05% - misc. skin and mucous membrane agents

New Zealand - English - Medsafe (Medicines Safety Authority)

leo pharma limited - ingenol mebutate 0.015%{relative} ((70 µg per tube)) - topical gel - 0.015% w/w - active: ingenol mebutate 0.015%{relative} ((70 µg per tube)) excipient: benzyl alcohol citric acid monohydrate hyetellose isopropyl alcohol purified water sodium citrate dihydrate - topical treatment of solar (actinic) keratoses in adults

New Zealand - English - Medsafe (Medicines Safety Authority)

leo pharma limited - ingenol mebutate 0.05%{relative} ((235 µg per tube)) - topical gel - 0.05% w/w - active: ingenol mebutate 0.05%{relative} ((235 µg per tube)) excipient: benzyl alcohol citric acid monohydrate hyetellose isopropyl alcohol purified water sodium citrate dihydrate - topical treatment of solar (actinic) keratoses in adults

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

alphapharm pty ltd - tamoxifen citrate -