European Union - English - 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).

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - immunosuppressants - multiple myelomalenalidomide krka 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 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 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 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.mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).follicular lymphomalenalidomide krka 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 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 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 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 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.mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

European Union - English - 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.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - atazanavir krka capsules, co-administered with low dose ritonavir, are 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).the choice of atazanavir krka 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)

krka, d.d., novo mesto - darunavir - hiv infections - antivirals for systemic use - 400 and 800 mgdarunavir krka, 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 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).600 mg darunavir krka, 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 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.

European Union - English - EMA (European Medicines Agency)

krka d.d. - pemetrexed disodium - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.pemetrexed krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - treatment of hiv-1 infectionemtricitabine/tenofovir disoproxil krka is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil krka 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 (see section 5.1pre-exposure prophylaxis (prep)emtricitabine/tenofovir disoproxil krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults at high risk.

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.

European Union - English - 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).

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.