Victoza Європейський Союз - литовська - EMA (European Medicines Agency)

victoza

novo nordisk a/s - liraglutidas - cukrinis diabetas, 2 tipas - narkotikai, vartojami diabetu - victoza fluorouracilu gydyti suaugusiems, paaugliams ir vaikams nuo 10 metų ir daugiau su nepakankamai kontroliuojamos 2 tipo cukriniu diabetu, kai dieta ir exerciseas monotherapy kai metforminas yra laikomas netinkamu dėl netolerancijos ar contraindicationsin, be kitų vaistų, skirtų gydyti diabetą. už studijų rezultatus, atsižvelgiant į derinius, poveikis glycaemic kontroliuoti širdies ir kraujagyslių įvykių, gyventojų, studijavo.

Xarelto Європейський Союз - литовська - EMA (European Medicines Agency)

xarelto

bayer ag - rivaroksabanas - arthroplasty, replacement; venous thromboembolism - antitromboziniai vaistai - xarelto, co-vartojama kartu su acetilsalicilo rūgštimi (asr), atskirai arba kartu su asa plius klopidogrelį ar ticlopidine, yra nurodyta prevencijos atherothrombotic renginių suaugusiems pacientams po ūminio vainikinių arterijų sindromo (acs) su padidėjusiu širdies biožymenys. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. venų tromboembolijos (vte) profilaktika suaugusiems pacientams, kuriems atliekama pasirinktinė klubo ar kelio sąnario pakeitimo operacija. gydant giliųjų venų trombozės (gvt) ir plaučių embolija (pe), prevencijos ir pasikartojančios gvt ir pe suaugusiems. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Hukyndra Європейський Союз - литовська - EMA (European Medicines Agency)

hukyndra

stada arzneimittel ag - adalimumabas - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - imunosupresantai - rheumatoid arthritishukyndra in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumabas buvo įrodyta, kad sumažinti greitį progresavimą, bendrą žalą, vertinant pagal x-ray ir gerinti fizinę funkciją, skiriant kartu su metotreksatu. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritishukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumabas nebuvo tirtas pacientams, jaunesniems negu 2 metų. enthesitis-related arthritishukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of ashukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumabas buvo įrodyta, kad sumažinti greitį progresavimą, periferinių sąnarių pažeidimai, kaip matuojamas x-ray sergant poliartritu simetriškus potipių ligos (žr. skyrių 5. 1), ir gerinti fizinę funkcija. psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 ir 5. crohn’s diseasehukyndra is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehukyndra is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitishukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitishukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Libmyris Європейський Союз - литовська - EMA (European Medicines Agency)

libmyris

stada arzneimittel ag - adalimumabas - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - imunosupresantai - rheumatoid arthritislibmyris in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumabas buvo įrodyta, kad sumažinti greitį progresavimą, bendrą žalą, vertinant pagal x-ray ir gerinti fizinę funkciją, skiriant kartu su metotreksatu. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritislibmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumabas nebuvo tirtas pacientams, jaunesniems negu 2 metų. enthesitis-related arthritislibmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of aslibmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumabas buvo įrodyta, kad sumažinti greitį progresavimą, periferinių sąnarių pažeidimai, kaip matuojamas x-ray sergant poliartritu simetriškus potipius ligą ir pagerinti fizinį funkcija. psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasislibmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 ir 5. crohn’s diseaselibmyris is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaselibmyris is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitislibmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitislibmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitislibmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitislibmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Adcirca (previously Tadalafil Lilly) Європейський Союз - литовська - EMA (European Medicines Agency)

adcirca (previously tadalafil lilly)

eli lilly nederland b.v. - tadalafilis - hipertenzija, plaučių vėžys - urologiniai preparatai - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. veiksmingumas buvo nustatytas idiopatinių pah (ipah) ir pah, susijusių su kolageno kraujagyslių ligomis. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Mycamine Європейський Союз - литовська - EMA (European Medicines Agency)

mycamine

astellas pharma europe b.v. - mikafunginas - candidiasis - antimycotics sisteminiam vartojimui - mycamine yra nurodyta:suaugusiems, paaugliams ≥ 16 metų amžiaus ir elderlytreatment invazinių kandidozė;gydymo oesophageal kandidozė pacientams, kuriems į veną terapija yra tinkama;profilaktiškai candida infekcijos pacientams, kuriems atliekama alogeninės kraujodaros kamieninių ląstelių transplantacijos ar pacientams, kurie tikimasi, kad neutropenia (absoliutus neutrofilų skaičius < 500 ląstelių/µl) 10 ar daugiau dienų. vaikų (įskaitant naujagimius) ir paaugliams < 16 metų agetreatment invazinių kandidozė. profilaktiškai candida infekcijos pacientams, kuriems atliekama alogeninės kraujodaros kamieninių ląstelių transplantacijos ar pacientams, kurie tikimasi, kad neutropenia (absoliutus neutrofilų skaičius < 500 ląstelių/µl) 10 ar daugiau dienų. sprendimą naudoti mycamine turėtų atsižvelgti į galimą riziką susirgti kepenų navikai. mycamine turėtų būti naudojami tik tuomet, jei kiti antifungals netinka.

Nuedexta Європейський Союз - литовська - EMA (European Medicines Agency)

nuedexta

jenson pharmaceutical services limited - dekstrometorfanas, quinidine - neuro-elgesio apraiškos - kiti nervų sistemos vaistai - nuedexta skiriamas simptominiam pseudobulbaro poveikio (pba) gydymui suaugusiems. efektyvumas buvo tiriamas tik pacientams, kuriems būdinga amiotrofinė šoninė sklerozė arba išsėtinė sklerozė.

Ristaben Європейський Союз - литовська - EMA (European Medicines Agency)

ristaben

merck sharp & dohme b.v. - sitagliptinas - cukrinis diabetas, 2 tipas - narkotikai, vartojami diabetu - suaugusiems pacientams, sergantiems 2 tipo cukriniu diabetu, ristaben yra nurodyta pagerinti glycaemic kontrolė:monotherapy:pacientams, nepakankamai kontroliuojama dieta ir mankšta vieni, ir kam metforminas netinka dėl kontraindikacijų ar netolerancija;kaip dual žodžiu terapija kartu su:metforminas, kai dieta ir mankšta plius metforminas vien nesuteikia pakankamos glycaemic kontrolė;sulfonilkarbamido dariniai, kai dieta ir mankšta plus maksimalus toleruojamas, dozę sulfonilkarbamido dariniai vien nesuteikia pakankamos glycaemic kontrolę ir, kai metforminas netinka dėl kontraindikacijų ar netoleravimas;a peroxisome proliferator aktyvuotas receptorius,-gama (ppary) agonistas (i. a thiazolidinedione), kai naudoti ppary agonistas yra tinkamas ir kai dieta ir mankšta plius ppary agonistas vien nesuteikia pakankamos glycaemic kontrolė;kaip trijų burnos terapija kartu su:sulfonilkarbamido dariniai ir metforminas, kai dieta ir mankšta plus dual terapija su šių vaistų nesuteikia pakankamos glycaemic kontrolė;ppary agonistas ir metforminas, kai naudoti ppary agonistas yra tinkamas ir kai dieta ir mankšta plus dual terapija su šių vaistų nesuteikia pakankamos kontrolės glycaemic. ristaben taip pat nurodė, kaip add-on insulinui (su arba be metforminas), kai dieta ir mankšta plius stabilus insulino dozę, nesuteikia pakankamos kontrolės glycaemic.

Rekovelle Європейський Союз - литовська - EMA (European Medicines Agency)

rekovelle

ferring pharmaceuticals a/s - folitropino delta - anovuliacija - lytiniai hormonai ir moduliatoriai lytinių organų sistemos, - kontroliuojamos kiaušidžių stimuliacijos keletą folikulų tvarkomus dirbtinio apvaisinimo technologijos (art) pvz., in vitro apvaisinimo (ivf) arba intracitoplazminė spermatozoido injekcija (icsi) ciklas moterims susirgti.

Riluzole Zentiva Європейський Союз - литовська - EMA (European Medicines Agency)

riluzole zentiva

zentiva k.s. - riluzolo - amiotrofinė šoninė sklerozė - kiti nervų sistemos vaistai - riluzole zentiva yra skirtas prailginti amyotrofinę šoninę sklerozę (als) sergantiems pacientams gyvenimo ar laiko prailginimą iki mechaninės ventiliacijos.. clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. išgyvenimo trukmė buvo apibrėžta kaip pacientams, kurie buvo gyvas, ne intubated. mechaninio vėdinimo ir tracheotomy-nemokamai. nėra įrodymų, kad riluzolo zentiva daro gydomąjį poveikį, variklio funkcija, plaučių funkcija, trūkčiojimams, raumenų jėgą ir motorinių simptomų. riluzolo zentiva nebuvo įrodyta, kad būti veiksmingos vėlesniuose etapuose als. saugumo ir veiksmingumo riluzolo zentiva tik studijavo als. todėl, riluzolo zentiva neturėtų būti naudojama pacientams, sergantiems bet kokia kita forma, variklis-neurone ligos.