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

astrazeneca pty ltd - zolmitriptan, quantity: 2.5 mg - tablet, film coated - excipient ingredients: hypromellose; macrogol 8000; titanium dioxide; sodium starch glycollate; lactose; microcrystalline cellulose; macrogol 400; magnesium stearate; iron oxide yellow - zomig is indicated for the acute treatment of migraine with or without aura.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals - zolmitriptan (unii: 2fs66th3yw) (zolmitriptan - unii:2fs66th3yw) - zolmitriptan 2.5 mg - zomig is indicated for the acute treatment of migraine with or without aura in adults. limitations of use zomig is contraindicated in patients with: risk summary there are no adequate data on the developmental risk associated with the use of zomig in pregnant women. in reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures (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 estimated rates of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk published data have suggested that women with migraine may be at increased risk of pree

USA - engelsk - NLM (National Library of Medicine)

dispensing solutions, inc. - zolmitriptan (unii: 2fs66th3yw) (zolmitriptan - unii:2fs66th3yw) - zolmitriptan 5 mg - zomig is indicated for the acute treatment of migraine with or without aura in adults. zomig should only be used where a clear diagnosis of migraine has been established. zomig is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see contraindications). safety and effectiveness of zomig have not been established for cluster headache, which is present in an older, predominantly male population. zomig should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including prinzmetal’s variant angina, or other significant underlying cardiovascular disease (see warnings and precautions). zomig should not be given to patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks (see warnings

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals - zolmitriptan (unii: 2fs66th3yw) (zolmitriptan - unii:2fs66th3yw) - zolmitriptan 5 mg - zomig nasal spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. limitations of use zomig is contraindicated in patients with: risk summary there are no adequate data on the developmental risk associated with the use of zomig in pregnant women. in reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures (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 estimated rates of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk published data have sugges

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - zolmitriptan (unii: 2fs66th3yw) (zolmitriptan - unii:2fs66th3yw) - zomig is indicated for the acute treatment of migraine with or without aura in adults. limitations of use - only use zomig if a clear diagnosis of migraine has been established. if a patient has no response to zomig treatment for the first migraine attack, reconsider the diagnosis of migraine before zomig is administered to treat any subsequent attacks. - zomig is not indicated for the prevention of migraine attacks. - safety and effectiveness of zomig have not been established for cluster headache. zomig is contraindicated in patients with: - ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including prinzmetal’s angina [see warnings and precautions (5.1)]. - wolff-parkinson-white syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see warnings and precautions (5.2)]. - history of stroke, transient ischemic attack (tia)

USA - engelsk - NLM (National Library of Medicine)

rebel distributors corp - zolmitriptan (unii: 2fs66th3yw) (zolmitriptan - unii:2fs66th3yw) - zolmitriptan 5 mg - zomig nasal spray is indicated for the acute treatment of migraine with or without aura in adults. zomig should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with zomig, the diagnosis of migraine should be reconsidered before zomig is administered to treat any subsequent attacks. zomig is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see contraindications (4.6)] . safety and effectiveness of zomig have not been established for cluster headache, which is present in an older, predominantly male population. zomig should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including prinzmetal’s variant angina, or other significant underlying cardiovascular dis

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - zolmitriptan - oral tablet - 2.5mg

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

grunenthal pharma s.a. - zolmitriptan - comprimido recubierto con pelÍcula - 2,5 mg - zolmitriptan 2,5 mg - zolmitriptán

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

astrazeneca farmaceutica spain, s.a. - zolmitriptan - excipientes: - preparados antimigraÑosos - agonistas selectivos de serotonina (5-ht1) - zolmitriptán

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

grunenthal pharma s.a. - zolmitriptan - solucion para pulverizacion nasal - 5 mg/dosis - zolmitriptan 5 mg - zolmitriptán