Μαλαισία - Αγγλικά - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - daclatasvir dihydrochloride -

Μαλαισία - Αγγλικά - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

gilead sciences malaysia sdn. bhd. - emtricitabine; tenofovir alafenamide fumarate; elvitegravir; cobicistat on silicon dioxide -

Ηνωμένο Βασίλειο - Αγγλικά - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - atazanavir sulfate; cobicistat - tablet - 300mg ; 150mg

Ισραήλ - Αγγλικά - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir disoproxil, elvitegravir and cobicistat - stribild is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with hiv 1 without known mutations associated with resistance to any of the three antiretroviral agents in stribild.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Ισραήλ - Αγγλικά - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir disoproxil, elvitegravir and cobicistat - stribild is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with hiv 1 without known mutations associated with resistance to any of the three antiretroviral agents in stribild.

Ισραήλ - Αγγλικά - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Ισραήλ - Αγγλικά - Ministry of Health

j-c health care ltd - etravirine - tablets - etravirine 100 mg - etravirine - etravirine - intelence is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-experienced adult patients including those with non-nucleoside reverse transcriptase inhibitor (nnrti) resistance. treatment history and when available resistance testing should guide the use of intelence. in patients who have experienced virological failure on an nnrti- and nucleoside or nucleotide reverse transcriptase inhibitor (n[t]rti) - containing regimen intelence is not recommended for use in combination with n(t)rtis only.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

janssen-cilag international nv - etravirine - hiv infections - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (hiv-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.this indication is based on week-48 analyses from two phase-iii trials in highly pretreated patients where intelence was investigated in combination with an optimised background regimen (obr) which included darunavir/ritonavir. the indication in paediatric patients is based on 48-week analyses of a single-arm, phase-ii trial in antiretroviral-treatment-experienced paediatric patients.

Ηνωμένο Βασίλειο - Αγγλικά - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - etravirine - tablet - 100mg

Ηνωμένο Βασίλειο - Αγγλικά - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - etravirine - tablet - 200mg