Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

sanofi pasteur - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - clopidogrel (as hydrogen sulfate) - myocardial infarction; acute coronary syndrome; peripheral vascular diseases; stroke - antitrombotična sredstva - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. za odrasle bolnike, ki trpijo za akutni koronarni sindrom:non-st segmentu višinskih akutni koronarni sindrom (nestabilna angina pektoris ali ne-q-val, miokardni infarkt), vključno z bolniki, ki opravljajo stent umestitev po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilne kisline (asa). st segmentu višinskih akutni miokardni infarkt, v kombinaciji s asa v medicinsko zdravljenih bolnikih, ki izpolnjujejo pogoje za thrombolytic terapija. preprečevanje atherothrombotic in thromboembolic dogodkov v atrijska fibrillationin odraslih bolnikov z atrijsko fibrilacijo, ki imajo vsaj en dejavnik tveganja za žilne dogodke, niso primerni za zdravljenje z antagonisti vitamina k (vka) in ki imajo nizko tveganje krvavitve, clopidogrel je indiciran v kombinaciji s asa za preprečevanje atherothrombotic in thromboembolic dogodkov, vključno z možgansko kap.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. učinek glivec na izid kostnega mozga presaditev ni bilo določeno. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment;, zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in / ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost glivec je na podlagi splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds / mpd, na hematoloških stopnjo odziva, v hes / cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in / ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z glivec pri bolnikih z mds / mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejeno (glej poglavje 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - cepiva - twinrix pediatric je indiciran za uporabo pri neimunskih dojenčkih, otrocih in mladostnikih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo s hepatitisom a in hepatitisom b.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inaktivirano), hepatitis b površinski antigen - hepatitis b; hepatitis a; immunization - cepiva - zdravilo twinrix adult je indicirano za uporabo pri neimunskih odraslih in mladostnikih, starih 16 let ali več, ki jim grozi okužba s hepatitisom a in hepatitisom b.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

norbrook laboratories (ireland) limited rossmore industrial estate monaghan irska proizvajalec odgovoren za sproščanje serij: norbrook manufacturing ltd -

Evropska unija - slovenščina - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastična sredstva - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastična sredstva - hormon-receptor-pozitivno napredno prsi cancerafinitor je primerna za zdravljenje hormon-receptor-pozitiven, her2/neu-negativne napredno raka na dojki, v kombinaciji z exemestane, v post-menopavzi, brez simptomatsko visceralne bolezni po ponovitev ali napredovanje po nesteroidna zaviralec aromataze. neuroendocrine tumorji trebušne slinavke originafinitor je primerna za zdravljenje unresectable ali metastatskim, dobro ali zmerno diferenciran neuroendocrine tumorji trebušne slinavke izvora pri odraslih z progresivna bolezen,. neuroendocrine tumorji iz prebavil ali pljuč originafinitor je primerna za zdravljenje unresectable ali metastatskim, dobro diferencirana (razred 1 ali razred 2) ne-funkcionalne neuroendocrine tumorji iz prebavil ali pljuč izvora pri odraslih z progresivna bolezen,. ledvične celice carcinomaafinitor je indiciran za zdravljenje bolnikov z napredovalim ledvičnim-cell carcinoma, katerih bolezen je napredovala na ali po zdravljenju z vegf-usmerjena terapija.