European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - darunavir - hiv infections - antivirals for systemic use - 400mg and 800 mg film-coated tabletsdarunavir krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection.darunavir krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection in adult patients (see section 4.2).darunavir krka d.d. 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art)-naïve (see section 4.2).art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with darunavir in such art-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600mg film-coated tabletsdarunavir krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection.darunavir krka d.d. 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):for the treatment of hiv-1 infection in antiretroviral treatment (art)-experienced adult patients, including those that have been highly pre-treated.for the treatment of hiv-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.in deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - carprofen - solution for injection - 50 milligram(s)/millilitre - carprofen - cats, dogs - n.s.a.i.d.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka d.d., novo mesto - naproxen sodium - film-coated tablet - 550 milligram(s) - propionic acid derivatives; naproxen

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - linezolid - film-coated tablet - 600 milligram(s) - other antibacterials; linezolid - antibacterials for systemic use, other antibacterials - linezolid krka is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible gram positive bacteria. in determining whether linezolid krka is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among gram positive bacteria should be taken into consideration

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - abiraterone acetate - prostatic neoplasms - endocrine therapy - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 10mg/10 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 10mg/5 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 5mg/10 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 5mg/5 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - clopidogrel (as hydrochloride) - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.