Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastilised ained - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. patsiendid, kellel on egfr-või kristallimise positiivne kasvaja mutatsioonid peaks ka saanud suunatud ravi enne saanud keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - efavirens - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - sustiva on näidustatud inimese immuunpuudulikkuse-viirus-1 (hiv-1) viirusevastane ravi-infektsiooniga täiskasvanutel, noorukitel ja lastel kolm aastat ja vanemad. sustiva ei ole piisavalt uuritud patsientidel, kaugelearenenud hiv-haigus, nimelt patsientidel, kellel cd4 arv < 50 rakku/mm3) või pärast rikke proteaas-inhibiitori (pi)-sisaldavad raviliikide. kuigi rist-resistentsust, efavirenz, mille pis ei ole dokumenteeritud, on praegu piisavad andmed efektiivsuse edasine kasutamine, pi-põhinevad kombineeritud ravi pärast rikke raviskeemi, mis sisaldab sustiva.

Euroopa Liit - eesti - EMA (European Medicines Agency)

dendreon uk ltd - autoloogse perifeerse vere mononukleaarsete rakkude, sealhulgas vähemalt 50 miljonit autoloogset cd54 + rakke aktiveeritud ja eesnäärme happeline fosfataas granulotsüütide-makrofaagide kolooniaid stimuleeriv faktor - eesnäärmevähk - muud immunostimulaatorid - provenge on näidustatud minimaalselt sümptomaatiline või asümptomaatiline (mittevistseraalse) kastreerida-resistentse metastaatilise eesnäärmevähi meessoost täiskasvanutel, kellel kemoteraapia ei ole veel kliiniliselt näidustatud.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirens - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - stocrin on näidustatud viirusevastase kombinatsioonravi korral inimese immuunpuudulikkuse viiruse-1 (hiv-1) -infektsiooniga täiskasvanutele, noorukitele ja kolmeaastastele lastele. stocrin ei ole piisavalt uuritud patsientidel, kaugelearenenud hiv-haigus, nimelt patsientidel, kellel cd4 arv < 50 rakku/mm3) või pärast rikke proteaas-inhibiitori (pi)-sisaldavad raviliikide. kuigi rist-resistentsust, efavirenz, mille pis ei ole dokumenteeritud, on praegu piisavad andmed efektiivsuse edasine kasutamine, pi-põhinevad kombineeritud ravi pärast rikke raviskeemi, mis sisaldab stocrin.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bayer ag - rivaroksabaan - arthroplasty, replacement; venous thromboembolism - antitrombootilised ained - xarelto, co-manustada atsetüülsalitsüülhape (asa) üksi või koos asa pluss clopidogrel või ticlopidine, on näidustatud ennetamine atherothrombotic sündmuste täiskasvanud patsientidel pärast äge koronaarsündroom (acs) kõrgenenud südame biomarkerite. 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. täiskasvanud patsientidel, kellele tehti plaaniline puusa- või põlveliigese asendamise operatsiooni venoosse trombemboolia (vte) ennetamine. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

krka, d.d., novo mesto - efavirenz, emtricitabine, tenofovir disoproxil naatriumoktenüülsuktsinaat-tärklis - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - efavirens / emtritsitabiin / tenofoviirdisoproksiil krka on fikseeritud annuste kombinatsioon efavirensi, emtritsitabiini ja tenofoviirdisoproksiili vahel. see on näidustatud inimese immuunpuudulikkuse viirus-1 (hiv-1) infektsiooni raviks 18-aastastel on saavutatud viroloogiline supressioon < 50 koopiat/ml oma praeguse kombineeritud antiretroviirusravi hiv-1 rna tase üle kolme kuu. patsiendid peavad on esinenud varem retroviiruste vastast ravi viroloogilise ja peab olema teada, et neil ei esinenud viirusetüvede koos ühtegi efavirensi sisalduva kolme osa suhtes olulist resistentsust / emtritsitabiini/tenofoviirdisoproksiilfumaraadi krka määramiseks ning oma esimese retroviirusevastase raviskeemi. tõendamine kasu efavirenz/emtricitabine/tenofovir disoproxil põhineb peamiselt 48-nädalase andmeid kliinilises uuringus, kus patsiendid, kellel on stabiilne virologic summutamise kohta kombineeritud retroviirusevastast ravi muuta efavirenz/emtricitabine/tenofovir disoproxil. andmed puuduvad praegu efavirensi/emtritsitabiini/tenofoviirdisoproksiilfumaraadi ravi mittesaanud või eelnevalt palju ravimeid saanud patsientidel kliinilistes uuringutes:. ei ole andmeid, et toetada kombinatsioon efavirenz/emtricitabine/tenofovir disoproxil ja muu retroviirusevastase ained.

Euroopa Liit - eesti - EMA (European Medicines Agency)

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vaktsiinid - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz. kasutada shingrix peab olema kooskõlas ametlike soovitustega.

Euroopa Liit - eesti - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - kartsinoom, squamous cell - antineoplastilised ained - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Euroopa Liit - eesti - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirine - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

Eesti - eesti - Ecolab

ecolab deutschland gmbh -