Europska Unija - engleski - 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.

Europska Unija - engleski - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - immunosuppressants - multiple myelomalenalidomide krka d.d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide krka d.d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide krka d.d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.follicular lymphomalenalidomide krka d.d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).multiple myelomalenalidomide krka d.d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide krka d.d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide krka d.d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.follicular lymphomalenalidomide krka d.d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Europska Unija - engleski - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - immunosuppressants - multiple myelomalenalidomide krka d.d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide krka d.d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide krka d.d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.myelodysplastic syndromeslenalidomide krka d.d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.follicular lymphomalenalidomide krka d.d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Irska - engleski - 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

Europska Unija - engleski - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - emtricitabine/tenofovir disoproxil krka d.d. is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil krka d.d. is 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.

Europska Unija - engleski - 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.

Europska Unija - engleski - EMA (European Medicines Agency)

krka, d.d., novo mesto - efavirenz, emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil krka 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 krka prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of 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 efavirenz/emtricitabine/tenofovir disoproxil.no data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.no data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Irska - engleski - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - duloxetine - gastro-resistant capsule, hard - 30 milligram(s) - other antidepressants; duloxetine - psychoanaleptics, other antidepressants - treatment of major depressive disorder. treatment of diabetic peripheral neuropathic pain. treatment of generalised anxiety disorder.

Irska - engleski - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - duloxetine - gastro-resistant capsule, hard - 60 milligram(s) - other antidepressants; duloxetine - psychoanaleptics, other antidepressants - treatment of major depressive disorder. treatment of diabetic peripheral neuropathic pain. treatment of generalised anxiety disorder.

Irska - engleski - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - amoxicillin; clavulanic acid - film-coated tablet - 500 mg/ 125 milligram(s) - combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor - : antibacterials for systemic use, combinations of penicillins, incl. beta-lactamase inhibitors - - acute bacterial sinusitis (adequately diagnosed) - acute otitis media - acute exacerbations of chronic bronchitis (adequately diagnosed) - community acquired pneumonia - cystitis - pyelonephritis - skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis. - bone and joint infections, in particular osteomyelitis.