Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - clarithromycin - film-coated tablet - 500 milligram(s) - macrolides; clarithromycin

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - clarithromycin - modified-release tablet - 500 milligram(s) - macrolides; clarithromycin

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - fenofibrate - film-coated tablet - 145 milligram(s) - fibrates; fenofibrate - serum lipid reducing agents / cholesterol and triglycerides reducers / fibrates. - it is indicated for: treatment of severe hypertriglyceridaemia with or without low hdl cholesterol,
mixed hyperlipidaemia when a statin is contraindicated or not tolerated,
mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and hdl cholesterol are not adequately controlled.

Ireland - English - HPRA (Health Products Regulatory Authority)

bgp products ireland limited - propafenone hydrochloride - film coated tablet - 150 milligram - antiarrhythmics, class ic - antiarrhythmics - symptomatic supraventricular tachyarrhythmias requiring treatment, such as av junctional tachycardia, supraventricular tachycardia in patients with wolff-parkinson-white (wpw) syndrome or paroxysmal atrial fibrillation. severe symptomatic ventricular tachyarrhythmia, if the physician considers these to be life-threatening.

Ireland - English - HPRA (Health Products Regulatory Authority)

bgp products ireland limited - propafenone hydrochloride - film coated tablet - 300 milligram - antiarrhythmics, class ic - antiarrhythmics - symptomatic supraventricular tachyarrhythmias requiring treatment, such as av junctional tachycardias, supraventricular tachycardias in patients with wolff-parkinson-white (wpw) syndrome or paroxysmal atrial fibrillation. severe symptomatic ventricular tachyarrhythmias, if the physician considers these to be life-threatening

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - atazanavir mylan, co-administered with low dose ritonavir, is indicated for the treatment of hiv 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 pi mutations). there are very limited data available from children aged 6 to less than 18 years.the choice of atazanavir mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tenofovir disoproxil - hiv infections - antivirals for systemic use - hiv-1 infectiontenofovir disoproxil 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 tenofovir disoproxil 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 tenofovir disoproxil 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).tenofovir disoproxil 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 tenofovir disoproxil 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 infectiontenofovir disoproxil 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.evidence of lamivudine-resistant hepatitis b virus.decompensated liver disease.tenofovir disoproxil 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, persistently elevated serum alt levels and histological evidence of active inflammation and/or fibrosis.

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

mylan health pty ltd - influenza virus haemagglutinin -

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

mylan health pty ltd - influenza virus haemagglutinin -