European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - calcium chloride dihydrate ph. eur.; magnesium chloride hexahydrate pheur; glucose monohydrate, ph eur; sodium chloride (nacl); sodium lactate (50%) -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - magnesium chloride hexahydrate pheur; sodium lactate solution (50%); glucose monohydrate, ph eur; sodium chloride (nacl); calcium chloride dihydrate ph. eur. -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - sodium chloride ph eur; calcium chloride dihydrate ph. eur.; magnesium chloride hexahydrate pheur; glucose monohydrate, ph eur; sodium lactate solution (50%) -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - calcium chloride dihydrate ph. eur.; magnesium chloride hexahydrate pheur; glucose monohydrate, ph eur; sodium chloride (nacl); sodium lactate solution (50%) -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - sodium chloride (nacl); calcium chloride dihydrate ph. eur.; magnesium chloride hexahydrate pheur; glucose monohydrate, ph eur; sodium lactate solution (50%) -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - sodium chloride (nacl); calcium chloride dihydrate ph. eur.; magnesium chloride hexahydrate pheur; glucose monohydrate, ph eur; sodium lactate solution (50%) -

Malta - English - Medicines Authority

apta medica internacional d.o.o likozarjeva ulica 6, 1000 ljubljana, , slovenia - amoxicillin, clavulanic acid - powder for solution for infusion or injection - amoxicillin 1000 mg clavulanic acid 200 mg - antibacterials for systemic use

Ireland - English - HPRA (Health Products Regulatory Authority)

as kalceks - calcium folinate - solution for injection/infusion - calcium folinate

European Union - English - EMA (European Medicines Agency)

allergan pharmaceuticals ireland - bimatoprost, timolol - glaucoma, open-angle, ocular hypertension - ophthalmologicals, - reduction of intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.