European Union - English - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, non-small-cell lung - antineoplastic agents - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

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

takeda pharmaceuticals america, inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon 8 mg - rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with rozerem should not be rechallenged with the drug. patients should not take rozerem in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with rozerem use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the rec

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

organon usa inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - remeronsoltab (mirtazapine) orally disintegrating tablets are indicated for the treatment of major depressive disorder. the efficacy of remeron (mirtazapine) tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the ef

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

bryant ranch prepack - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon 8 mg - rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with rozerem should not be rechallenged with the drug. patients should not take rozerem in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with rozerem use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the rec

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

teva pharma australia pty ltd - fremanezumab, quantity: 225 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; histidine; polysorbate 80; disodium edetate; sucrose; water for injections - ajovy is indicated for the preventive treatment of migraine in adults.

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

teva pharma australia pty ltd - fremanezumab, quantity: 225 mg - injection, solution - excipient ingredients: histidine; disodium edetate; histidine hydrochloride monohydrate; polysorbate 80; sucrose; water for injections - ajovy is indicated for the preventive treatment of migraine in adults.

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

ahava dead sea laboratories ltd - homosalate (unii: v06sv4m95s) (homosalate - unii:v06sv4m95s), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), ensulizole (unii: 9yq9di1w42) (ensulizole - unii:9yq9di1w42), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm) - - helps prevent sunburn

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

carilion materials management - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon 8 mg - rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with rozerem should not be rechallenged with the drug. patients should not take rozerem in conjunction with fluvoxamine (luvox) [see drug interaction (7)] . pregnancy category c in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses much greater than the recommended human dose (rhd) of 8 mg/day. there are no adequate and well-controlled studies in pregnant women. rozerem should be used during pregnancy only if the potential benefit justifies the pote

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

western first aid safety dba aramark - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - purpose benzalkonium chloride ......first aid antiseptic lidocaine hcl .................topical analgesic uses: • temporary relief of pain associated with minor cuts, scrapes,    and burns • helps protect against harmful bacteria

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

western first aid safety dba aramark - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), benzethonium chloride (unii: ph41d05744) (benzethonium - unii:1vu15b70bp) - benzethonium chloride ...topical antiseptic lidocaine ....................topical anisthetic uses for temporary relief of pain, treatment and helps prevent infection in • minor cuts and scrapes • for help in control of superficial bleeding