الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - pseudomembranoosne enterokoliit - suguhormoonid ja immunoglobuliinid, - zinplava on näidustatud clostridium difficile infektsiooni (cdi) kordumise ennetamiseks täiskasvanutel, kellel on kõrge risk cdi-d.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

tillotts pharma gmbh - fidaksomitsiin - clostridium infektsioonid - antidiarrheals, soole põletikuvastased / antiinfective ained - dificlir õhukese polümeerikattega tabletid on näidustatud ravi clostridioides difficile infektsioonide (cdi), tuntud ka kui c. raske-seotud diarröa (cdad), täiskasvanud ja pediaatriliste patsientide puhul, kelle kehakaal on vähemalt 12. 5 kg. tähelepanu tuleks pöörata euroopa liidu suuniste kohta asjakohast kasutamist antibakteriaalseid aineid. dificlir graanulite suukaudne suspensioon on näidustatud ravi clostridioides difficile infektsioonide (cdi), tuntud ka kui c. raske-seotud diarröa (cdad) täiskasvanud ja pediaatriliste patsientide sünnist kuni < 18-aastane. tähelepanu tuleks pöörata euroopa liidu suuniste kohta asjakohast kasutamist antibakteriaalseid aineid.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviiri - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

sanofi b.v. - türeotropiin alfa - kilpnäärme kasvajad - anterior hüpofüüsi lobe hormoonid ja nende analoogid, hüpofüüsi ja hüpotaalamuse hormoonid ja nende analoogid - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitiniib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastilised ained - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektiivsed immunosupressandid - haavandiline colitisentyvio on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse haavandilise koliidi, kes on ebaadekvaatne reaktsioon, kadunud vastuse, või olid sallimatu kas tavalise ravi või tuumori nekroosi faktor α (tnfa) antagonist. crohni diseaseentyvio on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse crohni tõbi, kes on ebaadekvaatne reaktsioon, kadunud vastuse, või olid sallimatu kas tavalise ravi või tuumori nekroosi faktor α (tnfa) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

sanofi b.v. - klofarabiin - prekursorko-lümfoblastne leukeemia-lümfoom - antineoplastilised ained - ravi ägeda lümfoblastse leukeemia (all lastel, kellel on tekkinud retsidiiv või ei allu pärast kaks eelnevat ravi saanud) ja kui ei ole muud ravivõimalus oodatud tulemuseks vastupidav vastust. ohutust ja efektiivsust on hinnatud algse diagnoosiga patsientidega ≤ 21-aastastel uuringutel.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

orphelia pharma sas - klofarabiin - prekursorko-lümfoblastne leukeemia-lümfoom - antineoplastilised ained - ravi ägeda lümfoblastse leukeemia (all lastel, kellel on tekkinud retsidiiv või ei allu pärast kaks eelnevat ravi saanud) ja kui ei ole muud ravivõimalus oodatud tulemuseks vastupidav vastust. ohutust ja efektiivsust on hinnatud algse diagnoosiga patsientidega ≤ 21-aastastel uuringutel.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - Ühenduse omandatud infektsioonid - antibacterials süsteemseks kasutamiseks, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 ja 5. tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - levofloksatsiin - cystic fibrosis; respiratory tract infections - antibacterials süsteemseks kasutamiseks, - quinsair on näidustatud krooniliste kopsu-nakkuste pseudomonas aeruginosa täiskasvanud patsientidel, kellel on tsüstiline fibroos. tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.