Israel - English - Ministry of Health

tzamal bio-pharma ltd - fosfomycin as sodium - powder for solution for infusion - fosfomycin as sodium 8 g - fosfomycin - fomicyt is indicated in all age groups for the treatment of the following infections when it is considered inappropriate to use antibacterial agents that are commonly recommended for their initial treatment:• complicated urinary tract infections• infective endocarditis• bone and joint infections• hospital-acquired pneumonia, including ventilator-associated pneumonia• complicated skin and soft tissue infection• bacterial meningitis• complicated intra-abdominal infections• bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed aboveconsideration should be given to official guidance on the appropriate use of antibacterial agents.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

orifarm a.s. - fosfomycin trometamol 5,631 g - eq. fosfomycin 3 g - granules for oral solution - fosfomycin

Malta - English - Medicines Authority

focused pharma ltd 37, geronimo abos street, iklin ikl 1022, malta - granules for oral solution - fosfomycin 3 g - antibacterials for systemic use

Kenya - English - Pharmacy and Poisons Board

fosfomycin trometamol - granules for oral solution in sachet - 3gm - fosfomycin

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - fosfomycin - granules for oral solution - fosfomycin

Kenya - English - Pharmacy and Poisons Board

fosfomycin trometamol - oral powder in sachet - 3 g - fosfomycin

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

ep plus group sdn. bhd. - fosfomycin trometamol -

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g;   - oral granules - 3 g - active: fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g   excipient: orange flv pdr fa-01142 (20375254) saccharin sodium sucrose tangerine flv pdr fa-00898 (20375218) - treatment of uncomplicated actue cystitis caused by pathogens susceptible to fosfomycin in adult women and adolescents aged over 12.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

sandoz south africa (pty) ltd - #n/a - not indicated - none

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - fosfomycin trometamol - granules for oral solution - other antibacterials; fosfomycin