Estados Unidos - inglês - NLM (National Library of Medicine)

glaxosmithkline llc - sotrovimab (unii: 1mtk0bpn8v) (sotrovimab - unii:1mtk0bpn8v) - the secretary of health and human services (hhs) has issued an emergency use authorization (eua) for the emergency use of sotrovimab 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 risk for progression to severe covid-19, including hospitalization or death. however, sotrovimab is not approved for this use (i.e., sotrovimab has not been demonstrated to be safe and effective for this use). limitations of authorized use benefit of treatment with sotrovimab has not been observed in patients hospitalized due to covid‑19. sars-cov-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with covid‑19 requiring high flow oxygen or mechanical ventilation [see warnings and precautions (5.2)] . sotrovimab is not fda-approved for any use, including for the treatment of covid-19.

África do Sul - inglês - South African Health Products Regulatory Authority (SAHPRA)

gilead sciences south africa (pty) ltd - infusion (parenteral) - see ingredients - each vial contains remdesivir 100,0 mg

Estados Unidos - inglês - NLM (National Library of Medicine)

merck sharp & dohme llc - molnupiravir (unii: ya84ki1vew) (molnupiravir - unii:ya84ki1vew) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of the unapproved product lagevrio™ for treatment of adults with mild-to-moderate coronavirus disease 2019 (covid-19): - who are at high risk for progression to severe covid-19, including hospitalization or death. refer to cdc website1 for additional details, and for - whom alternative covid-19 treatment options approved or authorized by fda are not accessible or clinically appropriate. limitations of authorized use - lagevrio is not authorized for use in patients who are less than 18 years of age [see warnings and precautions (5.3)] . - lagevrio is not authorized for initiation of treatment in patients hospitalized due to covid-192. benefit of treatment with lagevrio has not been observed in subjects when treatment was initiated after hospitalization due to covid-19 [see dosing and administration (2.1)] . - lagevrio is not authorized for use for longer than 5 consecutive days. - lagevrio is

Estados Unidos - inglês - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - nirmatrelvir (unii: 7r9a5p7h32) (nirmatrelvir - unii:7r9a5p7h32) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of paxlovid for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild-to-moderate coronavirus disease 2019 (covid-19) and who are at high risk1 for progression to severe covid-19, including hospitalization or death. limitations of authorized use paxlovid is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of covid-19 [see clinical studies (14.3)] . paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. paxlovid may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions: the state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced

Estados Unidos - inglês - NLM (National Library of Medicine)

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

União Europeia - inglês - EMA (European Medicines Agency)

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - immune sera and immunoglobulins, - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Estados Unidos - inglês - 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

Canadá - inglês - Health Canada

pfizer canada ulc - ritonavir; nirmatrelvir - tablet - 100mg; 150mg - ritonavir 100mg; nirmatrelvir 150mg

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - molnupiravir -

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - molnupiravir -