Unjoni Ewropea - Sloven - 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.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatitis c, kronični - antivirusi za sistemsko uporabo - ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) in adults (see sections 4. 2, 4. 4 in 5. ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4. 2, 4. 4 in 5.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

mylan pharmaceuticals limited - razagilinijev tartrat - parkinsonova bolezen - anti-parkinsonska zdravila - rasagilin mylan je indiciran za zdravljenje idiopatske parkinsonove bolezni (pd) kot monoterapijo (brez levodope) ali kot dodatno zdravljenje (z levodopo) pri bolnikih s končno nihanjem odmerka.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Unjoni Ewropea - Sloven - 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.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

viatris limited - tadalafil - hipertenzija, pljučnica - urološki - talmanco je indicirano pri odraslih za zdravljenje pljučne arterijske hipertenzije (pah) uvrščene, ki funkcionalno razreda ii in iii, izboljšati uresničevanje sposobnosti. učinkovitost so pokazali pri idiopatskem pah (ipah) in pri pah, povezani s kolagensko vaskularno boleznijo.

Slovenja - Sloven - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - amoksicilin; klavulanska kislina - filmsko obložena tableta - amoksicilin 875 mg / 1 tableta  klavulanska kislina125 mg / 1 tableta; klavulanska kislina 125 mg / 1 tableta - amoksicilin in zaviralec laktamaz beta

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - neoplazme dojke - endokrini terapija - fulvestrant je primerna za zdravljenje estrogen receptor pozitivno, lokalno napredno ali metastatskega raka dojke pri ženskah po menopavzi:ne prej, zdravljenih z endokrinih terapije, orwith ponovitve bolezni na ali po adjuvant anti-estrogen terapije, ali napredovanja bolezni na antiestrogen terapija.

Unjoni Ewropea - Sloven - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide hidroklorid - trombocitemija, esencialna - antineoplastična sredstva - anagrelide je primerna za zmanjšanje zvišane trombocitov šteje v grozi bistveno thrombocythaemia (et) bolnikov, ki so nestrpni do svoje trenutne terapije ali za katere je povišana trombocitov šteje se ne zmanjša na sprejemljivo raven z njihove trenutne terapije. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

Slovenja - Sloven - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - amoksicilin; klavulanska kislina - filmsko obložena tableta - amoksicilin 875 mg / 1 tableta  klavulanska kislina125 mg / 1 tableta; klavulanska kislina 125 mg / 1 tableta - amoksicilin in zaviralec laktamaz beta