Europeiska unionen - slovenska - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir - hepatitis c, kronični - antivirusi za sistemsko uporabo - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 in 5. za virus hepatitisa c (hcv) genotip določene dejavnosti, glej točki 4. 4 in 5. sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 in 5. za virus hepatitisa c (hcv) genotip določene dejavnosti, glej točki 4. 4 in 5.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - imipenem monohidrat, cilastatin natrij, relebactam monohidrat - gram-negativne bakterijskih okužb - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4. 4 in 5. - treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults. - treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4. 2, 4. 4 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imunosupresivi - 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) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. 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 in 5. 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) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. 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 in 5. 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).

Europeiska unionen - slovenska - EMA (European Medicines Agency)

gilead sciences ireland unlimited company - lenacapavir sodium - okužbe z virusom hiv - antivirusi za sistemsko uporabo - sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 in 5. sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 in 5.

Slovenien - slovenska - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - amoksicilin; klavulanska kislina - filmsko obložena tableta - amoksicilin 500 mg / 1 tableta  klavulanska kislina125 mg / 1 tableta; klavulanska kislina 125 mg / 1 tableta - amoksicilin in zaviralec laktamaz beta

Europeiska unionen - slovenska - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - darunavir, 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 (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):za zdravljenje okužbe z virusom hiv-1 okužba v protiretrovirusno zdravljenje (art)-izkušeni odraslih bolnikih, vključno s tistimi, ki so bili zelo pre-obravnava. za zdravljenje okužbe z virusom hiv-1 okužba pri pediatričnih bolnikih od starosti 3 let in najmanj 15 kg telesne teže. pri odločanju za uvedbo zdravljenja z darunavir co-daje z nizkim odmerkom ritonavir, previdni, upoštevati je treba zdravljenje zgodovino posameznih bolnikov in vzorcev mutacije, povezane z različnimi agenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 in 5. darunavir co-daje z nizkim odmerkom ritonavir je navedeno v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje bolnikov z virusom humane imunske pomanjkljivosti (hiv-1) okužbe.  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 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.  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. pri odločanju za uvedbo zdravljenja z darunavir v takih art-izkušeni bolniki, genotipa testiranje mora vodnik za uporabo darunavir (glej točki 4. 2, 4. 3, 4. 4 in 5.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberkuloza, odporna proti multidrugom - antimikobakterij - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. poleg drugimi zdravili za zdravljenje diabetesa tipa 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir - hepatitis c, kronični - antivirusi za sistemsko uporabo - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients 3 years of age and older (see sections 4. 2, 4. 4 in 5.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 in 5.