European Union - English - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - respiratory tract infections - antibacterials for systemic use, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Israel - English - Ministry of Health

truemed ltd, israel - amikacin as sulfate - suspension for inhalation - amikacin as sulfate 70 mg/ml - amikacin - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis. consideration should be given to official guidance on the appropriate use of antibacterial agents.

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

insmed incorporated - amikacin (unii: 84319sgc3c) (amikacin - unii:84319sgc3c) - limited population: arikayce® is indicated in adults, who have limited or no alternative treatment options, for the treatment of mycobacterium avium complex (mac) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. as only limited clinical safety and effectiveness data for arikayce are currently available, reserve arikayce for use in adults who have limited or no alternative treatment options. this drug is indicated for use in a limited and specific population of patients. this indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6. clinical benefit has not yet been established [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitati

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

minsmed -

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

minsmed -

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

insmed gk - amikacin sulfate - white milky suspension, inhalation

Canada - English - Health Canada

boumatic llc - lactic acid; sodium chlorite - solution - 2.64%; 0.64% - lactic acid 2.64%; sodium chlorite 0.64% - cattle

Canada - English - Health Canada

agrisan specialty chemical & pharmaceutical a division of agrisan inc - chlorhexidine acetate - solution - 0.5% - chlorhexidine acetate 0.5% - cattle

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

bayer plc - menthol; cetylpyridinium chloride - pastille - 330microgram/1gram ; 1.28mg/1gram

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - cetylpyridinium chloride levomenthol - pastilles - 0.033 + 0. %w/w