Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

janssen-cilag international nv - etravirine - Živ infekcijos - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, kartu su proteazės inhibitorius ir kitais antiretrovirusiniais vaistiniais preparatais, skirtas žmogaus-imunodeficito-viruso-1 tipo (Živ-1) infekcijai gydyti antiretrovirusiniais vaistais gydyti suaugusiems pacientams ir antiretrovirusiniais vaistais gydyti vaikams nuo šešerių metų amžiaus. Ši nuoroda yra pagrįstas savaitę-48 analizę, iš dviejų fazių-iii bandymai labai pretreated pacientams, kai intelence buvo tiriamas kartu su optimizuota fone režimas (stabilumui-svarbūs), kuris įtrauktas darunavir/ritonaviru. nuoroda į pediatrinių pacientų yra pagrįstas 48 savaitės analizes vienos rankos, etapą-ii tyrimo antiretrovirusinio gydymo-patyrę pediatrinių pacientų.

Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

roche registration gmbh - sakvinaviras - Živ infekcijos - antivirusiniai vaistai sisteminiam naudojimui - invirase skiriama Živ-1 infekuotiems suaugusiesiems gydyti. invirase turėtų būti skiriamas tik kartu su ritonaviru ir kitais antiretrovirusiniais vaistiniais preparatais.

Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - lopinavir, ritonaviru - Živ infekcijos - antivirals for systemic use, protease inhibitors - kaletra skiriamas kartu su kitais antiretrovirusiniais vaistiniais preparatais gydant žmogaus imunodeficito viruso (Živ-1) infekuotiems suaugusiesiems, paaugliams ir vaikams nuo 14 dienų ir vyresniems. pasirinkimas kaletra gydyti proteazė inhibitorius patyręs Živ-1 infekuotiems pacientams, kuriems turėtų būti grindžiamas atskirų virusinės rezistencijos tyrimų ir gydymo pacientų istorijos.

Eiropas Savienība - lietuviešu - 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 - antinavikiniai vaistai - 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. pacientams su egfr ar Šarminiai teigiamas navikas mutacijų, taip pat turėtų būti gautas tikslinis gydymas prieš gaunant 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.

Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - lopinavir, ritonaviru - Živ infekcijos - antivirusiniai vaistai sisteminiam naudojimui - lopinaviro/ritonaviro skiriamas kartu su kitais antiretrovirusiniais vaistiniais preparatais gydant žmogaus imunodeficito viruso (Živ-1) infekuotiems suaugusiesiems, paaugliams ir vyresniems nei 2 metų amžiaus. pasirinkimas lopinavir/ritonaviru gydyti proteazė inhibitorius patyręs Živ-1 infekuotiems pacientams, kuriems turėtų būti grindžiamas atskirų virusinės rezistencijos tyrimų ir gydymo pacientų istorijos.

Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

nordic group b.v. - metotreksatas - arthritis, psoriatic; psoriasis; arthritis, juvenile rheumatoid; arthritis, rheumatoid - antinavikiniai vaistai - nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (jia), when the response to nonsteroidal anti-inflammatory drugs (nsaids) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - Živ infekcijos - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsti vartojamas kartu su kitais antiretrovirusiniais vaistiniais preparatais, skirtais žmogaus imunodeficito viruso 1 (Živ 1) infekcijai gydyti suaugusiems žmonėms nuo 18 metų. genotypic bandymai turėtų vadovauti naudoti rezolsta.

Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

viiv healthcare bv - fosamprenaviro kalcis - Živ infekcijos - antivirusiniai vaistai sisteminiam naudojimui - telzir kartu su mažos dozės ritonaviras yra skirtas gydymas human-immunodeficiency-virus-type-1-infected suaugusiems, paaugliams ir vaikams bei šešerių metų kartu su kitais antiretrovirusiniais vaistiniais preparatais. saikingai antiretrovirusinis-patyrę suaugusieji, telzir kartu su mažos dozės ritonaviru nebuvo įrodyta, turi būti tokia pat veiksminga kaip lopinavir / ritonaviru. ne lyginamieji tyrimai buvo vykdomi su vaikų ar paauglių. labai nuo pretreated pacientams, naudoti telzir kartu su mažos dozės ritonaviru nebuvo pakankamai ištirtas. Į proteazė-inhibitorius-patyrusių pacientų, pasirinkimas telzir turėtų būti grindžiamas atskirų virusinės rezistencijos tyrimų ir gydymo istoriją.

Eiropas Savienība - lietuviešu - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumabas - išsėtinė sklerozė - selektyvūs imunosupresantai - 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 ir 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.

Lietuva - lietuviešu - SMCA (Valstybinė vaistų kontrolės tarnyba)

tamro, uab - lidokainas/prilokainas - kremas - 25 mg/25 mg/g