M-M-RVaxPro Evropska unija - slovenščina - EMA (European Medicines Agency)

m-m-rvaxpro

merck sharp & dohme b.v.  - ošpice virus enders' edmonston sev (v živo, zmanjšan), mumpsu virus jeryl lynn (raven b) sev (v živo, zmanjšan), virus rdečk wistar ra 27/3 sev (v živo, zmanjšan) - rubella; mumps; immunization; measles - cepiva - m-m-rvaxpro je označen za sočasno cepljenje proti ošpicam, mumpsu in rdečkam pri posameznikov 12 mesecev ali več. za uporabo v ošpice izbruhov, ali za post-izpostavljenost cepljenje, ali za uporabo v prej necepljenih otrocih, starejših od 12 mesecev, ki so v stiku z dovzetni nosečnice in osebe verjetno, da je dovzetna za mumpsu in rdečkam.

Tybost Evropska unija - slovenščina - EMA (European Medicines Agency)

tybost

gilead sciences ireland uc - cobicistat - okužbe z virusom hiv - antivirusi za sistemsko uporabo - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Tysabri Evropska unija - slovenščina - EMA (European Medicines Agency)

tysabri

biogen netherlands b.v. - natalizumab - multiple skleroza - selektivni imunosupresivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 in 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Vaborem Evropska unija - slovenščina - EMA (European Medicines Agency)

vaborem

menarini international operations luxembourg s.a. - meropenem trihidrat, vaborbactam - urinary tract infections; bacteremia; bacterial infections; respiratory tract infections; pneumonia; pneumonia, ventilator-associated - antibacterials za sistemsko uporabo, - vaborem je indicirano za zdravljenje naslednjih okužb pri odraslih:zapleteno okužbo sečil (cuti), vključno z pyelonephritiscomplicated znotraj trebušne okužbe (ciai)bolnišnično pridobljene pljučnice (hap), vključno z ventilator, povezanih pljučnica (vap). zdravljenje bolnikov z bacteraemia, ki se pojavlja v povezavi z ali obstaja sum, da je povezana z, vse okužbe, ki so navedene zgoraj. vaborem je tudi navedeno, za zdravljenje okužb zaradi aerobni gram-negativne organizmov pri odraslih z omejenimi možnosti zdravljenja. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Ulipristal Acetate Gedeon Richter Evropska unija - slovenščina - EMA (European Medicines Agency)

ulipristal acetate gedeon richter

gedeon richter plc. - ulipristal acetat - leiomyoma - spolni hormoni in zdravila genitalni sistem, - ulipristal acetata, ki je navedena za eno zdravljenje, seveda pre-operative zdravljenje zmerne do hude simptome maternice fibroids v odrasle ženske v rodni dobi. ulipristal acetata je primerna za občasno zdravljenje zmerne do hude simptome maternice fibroids v izobraževanje žensk v rodni dobi, ki niso primerni za operacijo.

Vantobra (previously Tobramycin PARI) Evropska unija - slovenščina - EMA (European Medicines Agency)

vantobra (previously tobramycin pari)

pari pharma gmbh - tobramycin - respiratory tract infections; cystic fibrosis - antibacterials za sistemsko uporabo, - vantobra je označen za upravljanje kronično pljučno okužbo, zaradi pseudomonas aeruginosa pri bolnikih, starih 6 let in več, s cistično fibrozo (cf). upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Tukysa Evropska unija - slovenščina - EMA (European Medicines Agency)

tukysa

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastična sredstva - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

Vafseo Evropska unija - slovenščina - EMA (European Medicines Agency)

vafseo

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - antianemični preparati - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Tyruko Evropska unija - slovenščina - EMA (European Medicines Agency)

tyruko

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 in 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Vanflyta Evropska unija - slovenščina - EMA (European Medicines Agency)

vanflyta

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukemija, myeloid - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.