New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - isotretinoin 10mg;   - soft gelatin capsule - 10 mg - active: isotretinoin 10mg   excipient: ferrous oxide gelatin glycerol soya bean oil, partially hydrogenated ferrous oxide yellow soya bean oil, hydrogenated soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. isotretinoin actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if isotretinoin actavis is used during pregnancy.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - isotretinoin 20mg;   - soft gelatin capsule - 20 mg - active: isotretinoin 20mg   excipient: ferrous oxide gelatin glycerol soya bean oil, partially hydrogenated ferrous oxide yellow soya bean oil, hydrogenated soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. isotretinoin actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if isotretinoin actavis is used during pregnancy.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - isotretinoin 5mg;   - soft gelatin capsule - 5 mg - active: isotretinoin 5mg   excipient: ferrous oxide gelatin glycerol soya bean oil, partially hydrogenated ferrous oxide yellow e172 soya bean oil, hydrogenated soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. isotretinoin actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if isotretinoin actavis is used during pregnancy.

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

alliance pharmaceuticals ltd - isotretinoin - oral capsule - 5mg

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

alliance healthcare (distribution) ltd - isotretinoin - oral capsule - 5mg

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

sun pharmaceutical industries europe b.v. - isotretinoin - oral capsule - 10mg

Canada - English - Health Canada

ranbaxy pharmaceuticals canada inc. - isotretinoin - capsule - 10mg - isotretinoin 10mg - misc. skin and mucous membrane agents

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

southern cross pharma pty ltd - isotretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: soya oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue fcf; ethanol; purified water; shellac; strong ammonia solution - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

strides pharma science pty ltd - isotretinoin, quantity: 20 mg - capsule, soft - excipient ingredients: disodium edetate; purified water; yellow beeswax; indigo carmine; butylated hydroxyanisole; brilliant scarlet 4r; dl-alpha-tocopherol; gelatin; soya oil; partially hydrogenated soya oil; glycerol; sorbitol solution (70 per cent) (non-crystallising); titanium dioxide; hydrogenated vegetable oil - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects asssociated with its use. isotretinoin should be reversed for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

strides pharma science pty ltd - isotretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: soya oil; dl-alpha-tocopherol; disodium edetate; butylated hydroxyanisole; partially hydrogenated soya oil; yellow beeswax; hydrogenated vegetable oil; gelatin; glycerol; sorbitol solution (70 per cent) (non-crystallising); brilliant scarlet 4r; iron oxide black; titanium dioxide; purified water - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.