Benlysta União Europeia - lituano - EMA (European Medicines Agency)

benlysta

glaxosmithkline (ireland) limited - belimumabas - lupus eritema, sisteminis - imunosupresantai - benlysta yra nurodyta kaip add-on terapija pacientams, nuo 5 metų ir vyresni su aktyvaus, autoantibody teigiamas sisteminė raudonoji vilkligė (srv) su aukšto laipsnio ligos aktyvumas (e. teigiamas anti dsdna ir mažai papildyti), nepaisant to, standartinė terapija. benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Levviax União Europeia - lituano - EMA (European Medicines Agency)

levviax

aventis pharma s.a. - telitromicinas - community-acquired infections; pharyngitis; bronchitis, chronic; pneumonia; tonsillitis; sinusitis - antibacterials sisteminio naudojimo, - levviax skyrimo metu reikėtų apsvarstyti oficialias rekomendacijas dėl tinkamo antibakterinių preparatų vartojimo ir vietinio atsparumo paplitimo (taip pat žr. 4 skyrių. 4 ir 5. levviax fluorouracilu gydyti šias infekcijas:pacientams, 18 metų ir vyresni:-bendruomenėje įgyta pneumonija, yra lengvas arba vidutinio sunkumo (žr. skyrių 4. - kai gydyti infekcijos sukeltą žinoma ar įtariama, beta-lactam ir/arba macrolide atsparių atmainų (pagal istoriją pacientų arba) nacionalinių ir/ar regiono atsparumas duomenis), kuriam antibakterinis spektras telithromycin (žr. skirsnius 4. 4 ir 5. 1):- Ūmus lėtinio bronchito paūmėjimo,- Ūmus sinusitisin pacientams nuo 12 metų ir vyresniems:- tonzilitas/pharyngitis sukelia streptococcus pyogenes, kaip alternatyva, kai beta lactam antibiotikai netinka šalyse/regionuose, kurių didelė paplitimas macrolide atsparus s. pyogenes, kai mediuoja ermtr ar mefa (žr. 4 skyrių). 4 ir 5.

Blenrep União Europeia - lituano - EMA (European Medicines Agency)

blenrep

glaxosmithkline (ireland) limited - belantamab mafodotin - daugybinė mieloma - antinavikiniai vaistai - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Ultomiris União Europeia - lituano - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinurija, paroksizminis - selektyvūs imunosupresantai - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Iblias União Europeia - lituano - EMA (European Medicines Agency)

iblias

bayer ag - octocog alfa - hemofilija a - antihemoraginiai - kraujavimo gydymas ir profilaktika pacientams, sergantiems hemofilija a (įgimtu viii faktoriaus trūkumu). iblias gali būti naudojamas visoms amžiaus grupėms.

Kogenate Bayer União Europeia - lituano - EMA (European Medicines Agency)

kogenate bayer

bayer ag  - octocog alfa - hemofilija a - antihemoraginiai - kraujavimo gydymas ir profilaktika pacientams, sergantiems hemofilija a (įgimtu viii faktoriaus trūkumu). Šio preparato sudėtyje nėra von willebrand faktorius, ir todėl nėra nurodyta von willebrand liga.

Idefirix União Europeia - lituano - EMA (European Medicines Agency)

idefirix

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - imunosupresantai - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Darzalex União Europeia - lituano - EMA (European Medicines Agency)

darzalex

janssen-cilag international n.v. - daratumumab - daugybinė mieloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. kartu su bortezomib, talidomidas ir dexamethasone gydyti suaugusiems pacientams su naujai diagnozuota, daugybine mieloma, kurie turi teisę autologinių kamieninių ląstelių transplantacijos. kartu su lenalidomide ir dexamethasone, ar bortezomib ir dexamethasone, gydyti suaugusiems pacientams, sergantiems daugybine mieloma, kurie gavo bent vieną prieš terapija. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. kaip monotherapy gydyti suaugusiems pacientams, sergantiems atsinaujino ir ugniai mieloma, kurių prieš terapija buvo proteasome inhibitorius ir imunomoduliacinis agentas ir kurie parodė, ligos progresavimo paskutinę terapija. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Myozyme União Europeia - lituano - EMA (European Medicines Agency)

myozyme

sanofi b.v. - alglukozidazė alfa - glikogeno kaupimo ligos ii tipas - kiti virškinimo trakto ir metabolizmo produktus, - myozyme yra skiriamas ilgalaikei fermento pakaitinei terapijai (ert) pacientams, kuriems diagnozuota pompe liga (rūgšties-α-gliukozidazės trūkumas). pacientams, sergantiems vėlai pradžią pompe liga veiksmingumo įrodymai yra ribotas,.

Tecvayli União Europeia - lituano - EMA (European Medicines Agency)

tecvayli

janssen-cilag international n.v. - teclistamab - daugybinė mieloma - antinavikiniai vaistai - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.