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

sandoz pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, modified release - excipient ingredients: colloidal anhydrous silica; glyceryl monostearate 40-55 per cent; gelatin; shellac; isopropyl alcohol; purified talc; propylene glycol; triethyl citrate; titanium dioxide; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; butan-1-ol; methacrylic acid copolymer; iron oxide black; ethanol; sodium stearylfumarate; purified water; iron oxide yellow; brilliant blue fcf; polysorbate 80; strong ammonia solution - dimethyl fumarate sandoz is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

sandoz pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, modified release - excipient ingredients: ethanol; iron oxide black; purified water; iron oxide yellow; gelatin; propylene glycol; triethyl citrate; purified talc; strong ammonia solution; butan-1-ol; shellac; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; methacrylic acid copolymer; isopropyl alcohol; glyceryl monostearate 40-55 per cent; colloidal anhydrous silica; brilliant blue fcf; sodium stearylfumarate; polysorbate 80; titanium dioxide - dimethyl fumarate sandoz is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

accelagen pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, enteric - excipient ingredients: magnesium stearate; titanium dioxide; croscarmellose sodium; microcrystalline cellulose; methacrylic acid copolymer; colloidal anhydrous silica; triethyl citrate; methacrylic acid - ethyl acrylate copolymer (1:1); gelatin; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - dimethyl fumarate msn is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

accelagen pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, enteric - excipient ingredients: gelatin; purified talc; methacrylic acid - ethyl acrylate copolymer (1:1); colloidal anhydrous silica; triethyl citrate; methacrylic acid copolymer; titanium dioxide; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - dimethyl fumarate msn is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

accelagen pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, enteric - excipient ingredients: purified talc; microcrystalline cellulose; gelatin; croscarmellose sodium; titanium dioxide; triethyl citrate; colloidal anhydrous silica; magnesium stearate; methacrylic acid copolymer; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - dimethyl fumarate msn is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

accelagen pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, enteric - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; methacrylic acid copolymer; purified talc; titanium dioxide; gelatin; triethyl citrate; magnesium stearate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - dimethyl fumarate msn is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

arrotex pharmaceuticals pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue fcf; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - dimethyl fumarate 240mg - modified release capsule - 240 mg - active: dimethyl fumarate 240mg excipient: colloidal silicon dioxide crospovidone sheffcoat clear asa 5x00294 sheffcoat white ent tec 5x00273 capsugel green op. c162 magnesium stearate microcrystalline cellulose povidone - indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

pharmathen international s.a. - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. risk summary there are no adequate data on the developmental risk associated with the use of dimethyl fumarate delayed-release capsules in pregnant women. in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation at clinically relevant doses [see data ]. in the u.s. general population, the estimated background risk of major birth defects and miscarr

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

accord healthcare inc. - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. reactions have included anaphylaxis and angioedema [see warnings and precautions ( 5.1)]. risk summary there are no adequate data on the developmental risk associated with the use of dimethyl fumarate delayed-release capsules in pregnant women. in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation at clinically relevant doses [ see data] . in the u.s. general population, the estimated background risk of majo