Litháen - litháíska - SMCA (Valstybinė vaistų kontrolės tarnyba)

krka, d.d., novo mesto - tert-butilamino perindoprilis/amlodipinas - tabletės - 5,7 mg/5 mg; 2,85 mg/2,5 mg - perindopril and amlodipine

Evrópusambandið - litháíska - EMA (European Medicines Agency)

roche registration gmbh - vemurafenibas - melanoma - antinavikiniai vaistai - vemurafenibas yra skirtas monoterapijai, skirtai suaugusiems pacientams, sergantiems braf-v600-mutacija teigiama neužsikrečiama ar metastazavusia melanoma.

Evrópusambandið - litháíska - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukemija, limfocitinė, lėtinė, b-ląstelė - antinavikiniai vaistai - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Evrópusambandið - litháíska - EMA (European Medicines Agency)

accord healthcare s.l.u. - vorikonazolas - aspergillosis; candidiasis; mycoses - antimycotics sisteminio naudojimo, triazolo dariniai - voriconazole yra plataus spektro, priešgrybeliniai triazolo agentas ir yra nurodyta suaugusiems ir vaikams nuo dviejų metų ir daugiau:gydymo invazinių aspergillosis;gydymo candidaemia ne neutropenic pacientams, gydymo fluconazole-atsparus rimtų invazinių candida infekcijos (įskaitant c. krusei);gydymo sunkių grybelinių infekcijų, kurias sukelia scedosporium spp. ir fusarium spp. voriconazole sutarimu turėtų būti skirti visų pirma pacientams su progressive, galbūt, gyvybei pavojingų infekcijų.

Evrópusambandið - litháíska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumabas - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antinavikiniai vaistai - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Evrópusambandið - litháíska - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - vorikonazolas - bacterial infections and mycoses; aspergillosis; candidiasis - antimycotics sisteminiam vartojimui - voriconazole yra plataus spektro, priešgrybeliniai triazolo agentas ir yra nurodyta suaugusiems ir vaikams nuo 2 metų ir daugiau:gydymo invazinių aspergillosis;gydymo candidaemia ne neutropenic pacientams, gydymo fluconazole-atsparus rimtų invazinių candida infekcijos (įskaitant c. krusei);gydymo sunkių grybelinių infekcijų, kurias sukelia scedosporium spp. ir fusarium spp. voriconazole turėtų būti skirti visų pirma pacientams su progressive, galbūt, gyvybei pavojingų infekcijų. profilaktika invazinių grybelinės infekcijos didelės rizikos alogeninės kraujodaros kamieninių ląstelių transplantacijos (hsct)gavėjai.

Evrópusambandið - litháíska - EMA (European Medicines Agency)

roche registration gmbh - aletinibo hidrochloridas - karcinoma, nesmulkiųjų ląstelių skausmas - antinavikiniai vaistai - alecensa kaip monotherapy yra nurodyta pirmos eilės gydymas suaugusiems pacientams, sergantiems anaplastic limfoma kinazės (Šarminio)-teigiama advanced nesmulkialąstelinio plaučių vėžio (nsclc). alecensa kaip monotherapy fluorouracilu ir folino suaugusių pacientų su alk‑teigiamas advanced nsclc anksčiau gydomi crizotinib.

Evrópusambandið - litháíska - 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.

Evrópusambandið - litháíska - EMA (European Medicines Agency)

pfizer europe ma eeig - vorikonazolas - candidiasis; mycoses; aspergillosis - antimycotics sisteminiam vartojimui - voriconazole, yra plataus spektro, priešgrybeliniai triazolo agentas ir yra nurodyta suaugusiems ir vaikams nuo 2 metų ir daugiau taip:gydymą invazinių aspergillosis;požiūris į candidaemianon-neutropenic pacientams, gydymo fluconazole-atsparus rimtų invazinių candida infekcijos (įskaitant c. krusei);gydymo sunkių grybelinių infekcijų, kurias sukelia scedosporium spp. ir fusarium spp. vfend turėtų būti skirti visų pirma pacientams su progressive, galbūt, gyvybei pavojingų infekcijų. profilaktika invazinių grybelinės infekcijos didelės rizikos alogeninės kraujodaros kamieninių ląstelių transplantacijos (hsct) gavėjai.

Litháen - litháíska - SMCA (Valstybinė vaistų kontrolės tarnyba)

krka, d.d., novo mesto - ramiprilis/hidrochlorotiazidas - tabletės - 5 mg/25 mg; 2,5 mg/12,5 mg - ramipril and diuretics