Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

gilead sciences ireland uc, ireland - sofosbuvir,velpatasvir - film-coated tablet - 400,100 mg,

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - aztreonam lysine - cystic fibrosis; respiratory tract infections - antibacterials for systemic use, - cayston is indicated for the suppressive therapy of chronic pulmonary infections due to pseudomonas aeruginosa in patients with cystic fibrosis (cf) aged 6 years and older.consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, tenofovir alafenamide - hiv infections - antivirals for systemic use - 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).

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir - hepatitis c, chronic - antivirals for systemic use - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - ledipasvir, sofosbuvir - hepatitis c, chronic - antivirals for systemic use - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).for hepatitis c virus (hcv) genotype-specific activity see sections 4.4 and 5.1.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide - hiv infections - antivirals for systemic use - treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml.,

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies.zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - tenofovir disoproxil fumarate - hepatitis b, chronic; hiv infections - antivirals for systemic use - hiv 1 infectionviread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.the choice of viread to treat antiretroviral experienced patients with hiv 1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectionviread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis b in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, withcompensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.the choice of viread to treat antiretroviral experienced patients with hiv 1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectionviread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis b in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg.the choice of viread to treat antiretroviral experienced patients with hiv 1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectionviread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis b in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum alt levels or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected adults.in adults, the demonstration of the benefit of viread in hiv 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).viread 245 mg film coated tablets are also indicated for the treatment of hiv 1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.the choice of viread to treat antiretroviral experienced patients with hiv 1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectionviread 245 mg film coated tablets are indicated for the treatment of 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 (see section 5.1).evidence of lamivudine resistant hepatitis b virus (see sections 4.8 and 5.1).decompensated liver disease (see sections 4.4, 4.8 and 5.1).viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis b in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected adults for whom a solid dosage form is not appropriate.in adults, the demonstration of the benefit of viread in hiv 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).the choice of viread to treat antiretroviral experienced patients with hiv 1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectionviread 33 mg/g granules are indicated for the treatment of chronic hepatitis b in adults for whom a solid dosage form is not appropriate 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 (see section 5.1).evidence of lamivudine resistant hepatitis b virus (see sections 4.8 and 5.1).decompensated liver disease (see sections 4.4, 4.8 and 5.1).viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis b in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - hiv infections - antivirals for systemic use - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir - hepatitis c, chronic - antivirals for systemic use - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).for hepatitis c virus (hcv) genotype specific activity, see sections 4.4 and 5.1.sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).for hepatitis c virus (hcv) genotype specific activity, see sections 4.4 and 5.1.