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

eli lilly and company - baricitinib (unii: isp4442i3y) (baricitinib - unii:isp4442i3y) -

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

eli lilly and company - bebtelovimab (unii: 8yl4syr6cu) (bebtelovimab - unii:8yl4syr6cu) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of bebtelovimab for the treatment of mild-to-moderate coronavirus disease 2019 (covid-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg): - with positive results of direct sars-cov-2 viral testing, and - who are at high risk1 for progression to severe covid-19, including hospitalization or death, and - for whom alternative covid-19 treatment options approved or authorized by fda are not accessible or clinically appropriate [see clinical studies (14.4)] . limitations of authorized use - bebtelovimab is not authorized for treatment of mild-to-moderate covid-19 in geographic regions where infection is likely to have been caused by a non-susceptible sars-cov-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. fda's determination and any updates will be available at: https://www.fda.gov/emergency-pr

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

moderna us, inc. - cx-038839 omicron (xbb.1.5) (unii: 4f9qrs7zv2) (cx-038839 omicron (xbb.1.5) - unii:4f9qrs7zv2) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of moderna covid-19 vaccine (2023-2024 formula) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months through 11 years of age. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the united states under certain circumstances including, but not limited to, when the secretary of hhs declares that the use of eua authority is justified, based on a determination that there is a public health emergency, or a significant potential for a public health emergency, that affects or

Canada - English - Health Canada

sanofi-aventis canada inc - riluzole - tablet - 50mg - riluzole 50mg - miscellaneous central nervous system agents

Canada - English - Health Canada

apotex inc - riluzole - tablet - 50mg - riluzole 50mg - miscellaneous central nervous system agents

Canada - English - Health Canada

mylan pharmaceuticals ulc - riluzole - tablet - 50mg - riluzole 50mg - miscellaneous central nervous system agents

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

rebel distributors corp - salmonella enterica subsp. enterica serovar typhi (unii: 760t5r8b3o) (salmonella enterica subsp. enterica serovar typhi - unii:760t5r8b3o) - salmonella enterica subsp. enterica serovar typhi 2 [cfu] - vivotif (typhoid vaccine live oral ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by salmonella typhi . routine typhoid vaccination is not recommended in the united states of america. selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to s. typhi , 2) persons with intimate exposure (e.g. household contact) to a s. typhi carrier, and 3) microbiology laboratorians who work frequently with s. typhi (7). there is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps. not all recipients of vivotif will be fully protected against typhoid fever. vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. the vaccine will not afford protection against species of salmonella other than salmonella

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

emergent travel health inc. - salmonella typhi ty21a live antigen (unii: 0mzi008m96) (salmonella typhi ty21a live antigen - unii:0mzi008m96) - salmonella typhi ty21a live antigen 6000000000 [cfu] - vivotif (typhoid vaccine live oral ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by salmonella typhi . routine typhoid vaccination is not recommended in the united states of america. selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to s. typhi , 2) persons with intimate exposure (e.g. household contact) to a s. typhi carrier, and 3) microbiology laboratorians who work frequently with s. typhi (7). there is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps. not all recipients of vivotif will be fully protected against typhoid fever. vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. the vaccine will not afford protection against species of salmonella other than salm

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

a-s medication solutions - salmonella typhi ty21a live antigen (unii: 0mzi008m96) (salmonella typhi ty21a live antigen - unii:0mzi008m96) - vivotif (typhoid vaccine live oral ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by salmonella typhi . routine typhoid vaccination is not recommended in the united states of america. selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to s. typhi , 2) persons with intimate exposure (e.g. household contact) to a s. typhi carrier, and 3) microbiology laboratorians who work frequently with s. typhi (7). there is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps. not all recipients of vivotif will be fully protected against typhoid fever. vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. the vaccine will not afford protection against species of salmonella other than salm

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

novavax, inc. - sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 (unii: uk9ak2in1p) (sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 - unii:uk9ak2in1p) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of novavax covid-19 vaccine, adjuvanted (2023-2024 formula) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. novavax covid-19 vaccine, adjuvanted is not licensed for any use. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: - determined that there is a public health emergency, or a significant potential for a public health emergency related to covid-19.4 - declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the covid-19 pandemic.5 an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved