Uni Eropa - Slovak - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karcinóm, pľúc bez malých buniek - iné antineoplastické činidlá, protein kinase inhibítory - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Uni Eropa - Slovak - EMA (European Medicines Agency)

pharmaand gmbh - peginterferón alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 a 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. s ohľadom na rozhodnutie o začatí liečby v pediatrických pacientov pozri časť 4. 2, 4. 4 a 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 a 5. pre vírusom hepatitídy c (hcv) genotyp špecifické činnosti, pozri časť 4. 2 a 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. pri rozhodovaní o tom, na začatie liečby v detstve, je dôležité zvážiť, inhibícia rastu vyvolané kombinácia terapie. reverzibilita inhibícia rastu je neistá. rozhodnutie na liečbu by mala byť predložená na prípad (pozri časť 4.

Uni Eropa - Slovak - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir - hepatitída c, chronická - antivirotiká na systémové použitie - 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 a 5. pre vírusom hepatitídy c (hcv) genotyp špecifické činnosti, pozri časť 4. 4 a 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 a 5. pre vírusom hepatitídy c (hcv) genotyp špecifické činnosti, pozri časť 4. 4 a 5.

Uni Eropa - Slovak - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - imipenem monohydrát, cilastatin sodík, relebactam monohydrát - gram-negatívne bakteriálne infekcie - 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 a 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 a 5. je treba vziať do úvahy oficiálne usmernenie o vhodnom používaní antibakteriálne agentov.

Uni Eropa - Slovak - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imunosupresíva - 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 indikovaný na liečbu dospelých predtým neliečených pacientov s myelómom je mladších, ktorí nie sú spôsobilí na transplantáciu. 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 a 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 indikovaný na liečbu dospelých predtým neliečených pacientov s myelómom je mladších, ktorí nie sú spôsobilí na transplantáciu. 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 a 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).

Uni Eropa - Slovak - EMA (European Medicines Agency)

gilead sciences ireland unlimited company - lenacapavir sodium - hiv infekcie - antivirotiká na systémové použitie - 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 a 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 a 5.

Slovakia - Slovak - ŠÚKL (Štátny ústav pre kontrolu liečiv)

krka, d.d., novo mesto, slovinsko - metformín a sitagliptín - 18 - antidiabetica (vrÁtane inzulÍnu)

Slovakia - Slovak - ŠÚKL (Štátny ústav pre kontrolu liečiv)

krka, d.d., novo mesto, slovinsko - metformín a sitagliptín - 18 - antidiabetica (vrÁtane inzulÍnu)

Slovakia - Slovak - ŠÚKL (Štátny ústav pre kontrolu liečiv)

krka, d.d., novo mesto, slovinsko - metformín a sitagliptín - 18 - antidiabetica (vrÁtane inzulÍnu)

Slovakia - Slovak - ŠÚKL (Štátny ústav pre kontrolu liečiv)

krka, d.d., novo mesto, slovinsko - metformín a sitagliptín - 18 - antidiabetica (vrÁtane inzulÍnu)