Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 75 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 150 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.

Singapore - English - HSA (Health Sciences Authority)

a. menarini singapore pte. ltd. - caffeine - tablet - 100 mg

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

tersera therapeutics, llc - ergotamine tartrate (unii: mru5xh3b48) (ergotamine - unii:pr834q503t) - ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia". coadministration of ergotamine with potent cyp 3a4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see precautions: drug interactions ), with some cases resulting in amputation. there have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine was coadministered, at least one resulting in death. because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of cyp 3a4 (e.g., ketoconazole, itraconazole) (see warnings: cyp 3a4 inhibitors ). ergomar® sublingual tablets may cause fetal harm when administered to pregnant women. ergomar® subli

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - nirmatrelvir, ritonavir - covid-19 virus infection - paxlovid is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe covid 19.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - caffeine,ergotamine tartrate -

Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

jaffar pharmacy - caffeine, ergotamine tartrate - tablet

Canada - English - Health Canada

paladin labs inc. - ergotamine tartrate; phenobarbital; belladonna - tablet (extended-release) - 0.6mg; 40.0mg; 0.2mg - ergotamine tartrate 0.6mg; phenobarbital 40.0mg; belladonna 0.2mg - antimuscarinics antispasmodics

Ireland - English - HPRA (Health Products Regulatory Authority)

3m health care limited - ergotamine tartrate -

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - dihydroergotamine mesylate - tablets - 2.5mg - antimigraine preparations