Nederland - nederlandsk - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

genthon b.v. microweg 22 6545 cm nijmegen - zopiclon - filmomhulde tablet - calciumwaterstoffosfaat 2-water (e 341) ; carmellose natrium (e 466) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; titaandioxide (e 171), - zopiclone

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

teva uk ltd - zopiclone - oral tablet - 3.75mg

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

teva uk ltd - zopiclone - oral tablet - 7.5mg

Belgia - fransk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris healthcare sa-nv - zopiclone 7,5 mg - comprimé pelliculé - 7,5 mg - zopiclone 7.5 mg - zopiclone

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.2)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbi

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions ( 5.3)] . risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits throughout or

USA - engelsk - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) thr

USA - engelsk - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits throughout orga

USA - engelsk - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbi

USA - engelsk - NLM (National Library of Medicine)

proficient rx lp - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbi