Europeiska unionen - slovenska - 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.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, rilpivirine hidroklorid, tenofovir alafenamide - okužbe z virusom hiv - antivirusi za sistemsko uporabo - zdravljenje odraslih in mladostnikov (starih 12 let in starejši z telesne teže vsaj 35 kg), okuženih z virusom človeške imunske pomanjkljivosti (hiv 1) 1 brez znane mutacije, povezane z odpornost proti niso nukleozidni zaviralec reverzne transkriptaze (nnrti) razreda, so ali emtricitabine in z virusna obremenitev ≤ 100.000 hiv 1 rna kopij/ml.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferon alfa-2b - hepatitis c, kronični - immunostimulants, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. prosimo, da ribavirin in boceprevir povzetkov glavnih značilnosti zdravila (smpcs), ko pegintron se uporablja v kombinaciji s temi zdravili. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. pegintron v kombinaciji z ribavirin (bitherapy) je indiciran za zdravljenje chc okužbe pri odraslih bolnikih, ki so predhodno nezdravljenih vključno z bolniki s klinično stabilno hiv co-okužbe in pri odraslih bolnikih, ki niso predhodnem zdravljenju z interferonom-alfa (pegylated ali ne-pegylated) in ribavirin kombinacija terapije ali interferonom-alfa monotherapy. interferon monotherapy, vključno z pegintron, je indicirana predvsem v primeru, nestrpnosti ali contraindication za ribavirin. prosimo, glejte povzetek glavnih značilnosti zdravila ribavirin, ko pegintron se uporablja v kombinaciji z ribavirin. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. ko se odločate, da ne odloži zdravljenje do odrasle dobe, je pomembno upoštevati, da je kombinacija terapije povzročile zaviranja rasti, ki so lahko nepopravljive v nekaterih bolnikih, ki. odločitev za zdravljenje mora biti od primera do primera. prosimo, glejte povzetek glavnih značilnosti zdravila ribavirin za kapsule ali peroralna raztopina, ko pegintron se uporablja v kombinaciji z ribavirin.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitis c, kronični - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. prosimo, da ribavirin in boceprevir povzetkov glavnih značilnosti zdravila (smpcs), ko viraferonpeg se uporablja v kombinaciji s temi zdravili. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg v kombinaciji z ribavirin (bitherapy) je indiciran za zdravljenje chc okužbe pri odraslih bolnikih, ki so predhodno nezdravljenih vključno z bolniki s klinično stabilno hiv co-okužbe in pri odraslih bolnikih, ki niso prejšnje zdravljenje z interferonom alfa (pegylated ali ne-pegylated) in ribavirin kombinacija terapije ali interferon alfa monotherapy. interferon monotherapy, vključno z viraferonpeg, je indicirana predvsem v primeru, nestrpnosti ali contraindication za ribavirin. prosimo, glejte povzetek glavnih značilnosti zdravila ribavirin, ko viraferonpeg se uporablja v kombinaciji z ribavirin. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. ko se odločate, da ne odloži zdravljenje do odrasle dobe, je pomembno upoštevati, da je kombinacija terapije povzročile zaviranja rasti, ki so lahko nepopravljive v nekaterih bolnikih, ki. odločitev za zdravljenje mora biti od primera do primera. prosimo, glejte povzetek glavnih značilnosti zdravila ribavirin za kapsule ali peroralna raztopina, ko viraferonpeg se uporablja v kombinaciji z ribavirin.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

paion deutschland gmbh - remimazolam besilate - zavestna sedacija - psiholeptiki - remimazolam is indicated in adults for procedural sedation. remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

stemline therapeutics b.v. - elacestrant - neoplazme dojke - endokrini terapija - orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (er) positive, her2-negative, locally advanced or metastatic breast cancer with an activating esr1 mutation who have disease progression following at least one line of endocrine therapy including a cdk 4/6 inhibitor.

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

krka, d.d., novo mesto - ezetimib, simvastatin - tableta - ezetimib 10 mg / 1 tableta; simvastatin 40 mg / 1 tableta - simvastatin in ezetimib

Europeiska unionen - slovenska - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabin - predkroglomerna limfoma t-celična limfoblastna levkemija - antineoplastična sredstva - nelarabine je indiciran za zdravljenje bolnikov z t-celic acute lymphoblastic levkemijo (t-all) in t-celic lymphoblastic limfom (t-lbl), katerih bolezen ni odgovorila, ali je relapsed po zdravljenju z vsaj dvema kemoterapijo regimens. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - memantinijev klorid - alzheimerjeva bolezen - druga zdravila proti demenciji - zdravljenje bolnikov z zmerno do hudo alzheimerjevo boleznijo.

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

krka, d.d., novo mesto - ezetimib; simvastatin - tableta - ezetimib 10 mg / 1 tableta  simvastatin10 mg / 1 tableta; simvastatin 10 mg / 1 tableta - simvastatin in ezetimib