Canada - English - Health Canada

sunovion pharmaceuticals canada inc - apomorphine hydrochloride - film, soluble - 15mg - apomorphine hydrochloride 15mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - apomorphine hydrochloride - film, soluble - 20mg - apomorphine hydrochloride 20mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - apomorphine hydrochloride - film, soluble - 25mg - apomorphine hydrochloride 25mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - apomorphine hydrochloride - film, soluble - 30mg - apomorphine hydrochloride 30mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - lefamulin (lefamulin acetate) - solution - 10mg - lefamulin (lefamulin acetate) 10mg - other miscellaneous antibacterial agents*

Canada - English - Health Canada

sunovion pharmaceuticals canada inc - lefamulin (lefamulin acetate) - tablet - 600mg - lefamulin (lefamulin acetate) 600mg - other miscellaneous antibacterial agents*

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

aphena pharma solutions - tennessee, llc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 2 mg - 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)] . 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/d

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

a-s medication solutions - 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 )] . 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 rabbits (

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

remedyrepack inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - xopenex (levalbuterol hcl) inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. xopenex inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions ( 5.6) ]. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of xopenex inhalation solution in pregnant women. because animal reproduction studies are not always predictive of human response, xopenex inhalation solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemic albut

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

dr. reddys laboratories inc - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for:   • monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)] .   • adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)].   • known  hypersensitivity  to  lurasidone  hcl  or  any  components  in  the  formulation. angioedema has been observed with lurasidone [see adverse reactions ( 6.1)] . • strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions ( 7.1)]. • strong cyp3a4 inducers (e.g., rifampin, avasimibe, st.  john’s wort, phenytoin, carbamazepine, etc.) [see drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride