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

fresenius kabi usa, llc - mitoxantrone hydrochloride (unii: u6usw86rd0) (mitoxantrone - unii:bz114nvm5p) - mitoxantrone 2 mg in 1 ml - mitoxantrone injection, usp is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). mitoxantrone injection, usp is not indicated in the treatment of patients with primary progressive multiple sclerosis. the clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability.  mitoxantrone injection, usp in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. mi

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

the medicines company - vaborbactam (unii: 1c75676f8v) (vaborbactam - unii:1c75676f8v), meropenem (unii: fv9j3ju8b1) (meropenem anhydrous - unii:yop6px0bao) - vaborbactam 1 g in 2 g - vabomere™ is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cuti) including pyelonephritis caused by the following susceptible microorganisms: escherichia coli , klebsiella pneumoniae , and enterobacter cloacae species complex. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vabomere and other antibacterial drugs, vabomere should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. vabomere is contraindicated in patients with known hypersensitivity to any components of vabomere (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphyla

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

perrigo new york inc - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 12.5 mg in 1.25 g - testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: limitations of use: pregnancy category x [see contraindications (4) ]: testosterone gel is contraindicated during pregnancy or in women who may become pregnant. testosterone is teratogenic and may cause fetal harm. exposure of a female fetus to androgens, such as testosterone, may result in varying degrees of virilization. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. although it is not known how much testosterone transfers into human milk, testosterone gel is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. testosterone and other androgens may adversely affect lactation. [see contraindications (4) ]. safety and efficacy of testosterone gel in pediatric males less than 18 years old ha

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

gw pharma ltd - cannabidiol; dronabinol - spray - 2.5mg/1dose ; 2.7mg/1dose

Canada - English - Health Canada

abbvie corporation - linaclotide - capsule - 72mcg - linaclotide 72mcg - miscellaneous gi drugs

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

roche (malaysia) sdn. bhd. - tocilizumab -

Canada - English - Health Canada

glaxosmithkline inc - mepolizumab - solution - 100mg - mepolizumab 100mg - immunosuppressive agents

Canada - English - Health Canada

glaxosmithkline inc - mepolizumab - solution - 100mg - mepolizumab 100mg - immunosuppressive agents

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - mepolizumab - powder for solution for injection - mepolizumab 100 mg - mepolizumab - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patientschronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with corticosteroids and surgery in the last 10 years do not provide adequate disease control.eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa).hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - mepolizumab - solution for injection - mepolizumab 100 mg / 1 ml - mepolizumab - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patientschronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with corticosteroids and surgery in the last 10 years do not provide adequate disease control.eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa).hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.