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

biogen australia pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, modified release - excipient ingredients: colloidal anhydrous silica; gelatin; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; croscarmellose sodium; polysorbate 80; simethicone; methacrylic acid copolymer; magnesium stearate; brilliant blue fcf; microcrystalline cellulose; iron oxide yellow; triethyl citrate; sodium lauryl sulfate; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - tecfidera is 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)

a-s medication solutions - 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 miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown.  data   animal data in rats administered dmf orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. this dose also produced evidence of maternal toxicity (reduced body weight). plasma exposure (auc) for monomethyl fumarate (mmf), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (rhd) of 480 mg/day. in rabbits administered dmf orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. the plasma auc for mmf at the no-effect dose is approximately 5 times that in humans at the rhd.  oral administration of dmf (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. neurobehavioral impairment was observed at all doses. a no-effect dose for developmental toxicity was not identified. the lowest dose tested was associated with plasma auc for mmf lower than that in humans at the rhd. risk summary   there are no data on the presence of dmf or mmf in human milk. the effects on the breastfed infant and on milk production are unknown.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dimethyl fumarate delayed-release capsules and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of dimethyl fumarate delayed-release capsules did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

nufarm australia limited - chlorthal dimethyl - water dispersible granule - chlorthal dimethyl benzoic acid-arylaliphatic active 900.0 g/kg - herbicide - bean | brassica - asian | brassica leafy vegetables - see label | broccoli | brussels sprouts | cabbage | carrot | castor bean | - annual sedge(cyperus spp.) - suppression | apple-of-peru | barnyard grass - seed (echinochloa spp.) | black bindweed | blackberry nightshade | blue pimpernel | caltrop - tribulis terrestis | canary grass | cape gooseberry | capeweed | chickweed | climbing buckwheat | columbus grass | common heliotrope | corn spurry | crowsfoot grass | dandelion - taraxacum officinale | deadnettle | dock | dodder | erodium spp. | fat hen | fescue | giant or black pigweed | green amaranth | innocent weed or grass | johnson grass | kidney weed | liverseed or urochloa grass | mossman river grass / spiny burr grass | mouse-ear chickweed | paddy melon | paterson's curse | perennial pigweed | petty spurge | pigeon grass | prince of wales feather - seed | red natal grass | redshank - prince of wales feather | ribwort, ribgrass or lamb's tongue | ryegrass | sand burr | scarlet or red pimpernel | soft roly poly | sow or milk thistle | spiny emex | stagger weed | stinging or dwarf nettle | summer or crab grass - d. sanguinalis | three c

Canada - English - Health Canada

sandoz canada incorporated - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg - miscellaneous central nervous system agents

Canada - English - Health Canada

sandoz canada incorporated - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg - miscellaneous central nervous system agents

Canada - English - Health Canada

jamp pharma corporation - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg - miscellaneous central nervous system agents

Canada - English - Health Canada

jamp pharma corporation - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg - miscellaneous central nervous system agents

Canada - English - Health Canada

sandoz canada incorporated - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg - miscellaneous central nervous system agents

Canada - English - Health Canada

sandoz canada incorporated - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg - miscellaneous central nervous system agents

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

accord healthcare 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.