오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: indigo carmine aluminium lake; magnesium stearate; croscarmellose sodium; titanium dioxide; triacetin; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; hypromellose - treatment of hiv-1 infection,truvada is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see clinical studies).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; triacetin - viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,viread is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,viread is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation. viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults. viread is indicated for the treatment of chronic hepatitis b in adults with evidence of active viral replication and active liver inflammation.

이스라엘 - 영어 - Ministry of Health

incyte biosciences israel ltd, israel - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 15 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

이스라엘 - 영어 - Ministry of Health

incyte biosciences israel ltd, israel - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 15 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

이스라엘 - 영어 - Ministry of Health

incyte biosciences israel ltd, israel - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 45 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

이스라엘 - 영어 - Ministry of Health

incyte biosciences israel ltd, israel - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 45 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

이스라엘 - 영어 - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 10 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).בקשה לשינוי התוויה: 14/8/19addition of new info to posology section: patients undergoing haemodialysis

이스라엘 - 영어 - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 25 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).בקשה לשינוי התוויה: 14/8/19addition of new info to posology section: patients undergoing haemodialysis

이스라엘 - 영어 - Ministry of Health

gilead sciences israel ltd - tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg - tenofovir disoproxil - viread is indicated for the treatment of :1. hiv 1 infected adults and pediatric patients 12 years of age and older in combination with other antiretroviral medicinal products for the treatment of hiv. 2. chronic hepatitis b in adults with: • compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. • decompensated liver disease

이스라엘 - 영어 - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 10 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).