Afinitor Европейски съюз - латвийски - EMA (European Medicines Agency)

afinitor

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastiski līdzekļi - hormonu receptoru pozitīvs papildu krūts cancerafinitor ir indicēts, lai ārstētu hormonu receptoru pozitīvs, her2/neu-negatīvs papildu krūts vēzi, kopā ar exemestane, sievietēm pēc menopauzes, bez bojājumu pazīmēm iekšējo orgānu slimības pēc atkārtošanās vai progresēšanu pēc nesteroīds aromatāzes inhibitors. neiroendokrīnās audzēji (aizkuņģa dziedzera originafinitor ir indicēts, lai ārstētu unresectable vai metastātiska, labi vai vidēji diferencēta neiroendokrīnās audzēji (aizkuņģa dziedzera izcelsmes pieaugušajiem ar progresējoša slimība. neiroendokrīnās audzēji, kuņģa un zarnu trakta vai plaušu originafinitor ir indicēts, lai ārstētu unresectable vai metastātiska, labi diferencētas (1. pakāpē vai pakāpes, 2) ne-funkcionāliem neiroendokrīnās audzēji, kuņģa un zarnu trakta vai plaušu izcelsmes pieaugušajiem ar progresējoša slimība. nieru šūnu carcinomaafinitor ir indicēts, lai ārstētu pacientiem ar progresējošu nieru šūnu karcinomu, kuru slimība ir progresējusi vai pēc apstrādes ar vegf-mērķtiecīga terapija.

Cabometyx Европейски съюз - латвийски - EMA (European Medicines Agency)

cabometyx

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastiski līdzekļi - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Invirase Европейски съюз - латвийски - EMA (European Medicines Agency)

invirase

roche registration gmbh - saquinavir - hiv infekcijas - pretvīrusu līdzekļi sistēmiskai lietošanai - invirase indicēts hiv-1 inficētiem pieaugušiem pacientiem. invirase drīkst lietot tikai kopā ar ritonavīru un citiem pretretrovīrusu līdzekļiem.

Keytruda Европейски съюз - латвийски - EMA (European Medicines Agency)

keytruda

merck sharp & dohme b.v. - pembrolizumabs - 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 - antineoplastiski līdzekļi - 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. pacientiem ar egfr vai bĀziskĀ pozitīvas mutācijas audzēja arī būtu saņēmuši mērķtiecīgu terapiju, pirms saņem 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.

Kisplyx Европейски съюз - латвийски - EMA (European Medicines Agency)

kisplyx

eisai gmbh - lenvatinib mesilate - karcinoma, nieru šūna - antineoplastiski līdzekļi - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Votrient Европейски съюз - латвийски - EMA (European Medicines Agency)

votrient

novartis europharm limited  - pazopanib - karcinoma, nieru šūna - antineoplastiski līdzekļi - nieru šūnu karcinomas (rcc)votrient ir norādīts pieaugušajiem pirmās līnijas attieksmi pret papildu nieru šūnu karcinomas (rcc) un pacientiem, kuri ir saņēmuši pirms cytokine terapija uzlabotas slimības. mīksto audu sarkoma (sts)votrient ir norādīts ārstēšanai pieaugušiem pacientiem ar selektīviem apakštipi papildu mīksto audu sarkoma (sts), kuri ir saņēmuši pirms ķīmijterapijas par metastātiska slimība vai kuri ir bijuši 12 mēnešu laikā pēc tam, kad (neo)palīgvielu terapija. efektivitāte un drošība ir tikai konstatēts dažās sts histoloģisko audzēju apakštipi.

Yervoy Европейски съюз - латвийски - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - ipilimumabs - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastiski līdzekļi - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 un 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

Voriconazole Accord Европейски съюз - латвийски - EMA (European Medicines Agency)

voriconazole accord

accord healthcare s.l.u. - voriconazole - aspergillosis; candidiasis; mycoses - antimycotics līdzekļi sistēmiskai lietošanai, triazola atvasinājumi - voriconazole ir plaša spektra, triazola pretsēnīšu līdzeklis un tiek norādīts pieaugušajiem un bērniem vecumā līdz diviem gadiem un iepriekš šādi:ārstēšanā invazīvās aspergillosis;ārstēšana candidaemia, kas nav neutropenic pacientiem;ārstēšana fluconazole-izturīgs smagu invazīvo candida infekcijas (tostarp c. krusei);Ārstēšana smagu sēnīšu infekcijas, ko izraisa scedosporium spp. un fusarium spp. voriconazole accord būtu jāievada galvenokārt pacientiem ar progressive, iespējams, dzīvībai bīstamas infekcijas.