Keytruda Evropska unija - slovenščina - EMA (European Medicines Agency)

keytruda

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 - antineoplastična sredstva - 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. pri bolnikih z egfr ali alk pozitivnih tumorjev mutacije, ki naj bi prav tako prejel usmerjena terapija pred prejemom 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.

Votrient Evropska unija - slovenščina - EMA (European Medicines Agency)

votrient

novartis europharm limited  - pazopanib - karcinom, ledvična celica - antineoplastična sredstva - ledvična-cell carcinoma (rkc)votrient je navedeno v odraslih za prvo linijo zdravljenja naprednih ledvic-cell carcinoma (rkc) in pri bolnikih, ki so prejeli pred citokin terapije za napredno bolezni. mehka tkiva sarkom (sts)votrient je indiciran za zdravljenje odraslih bolnikov s selektivno podtipov naprednih mehka tkiva sarkom (sts), ki jih prejeli v pred kemoterapijo za metastatskim bolezni ali ki so napredovali v roku 12 mesecev po (neo)adjuvant therapy. učinkovitost in varnost so le bile ustanovljene v nekaterih sts tumorja, histološki podtipov.

Euthyrox 100 mikrogramov tablete Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

euthyrox 100 mikrogramov tablete

merck d.o.o. - natrijev levotiroksinat - tableta - natrijev levotiroksinat 100 µg / 1 tableta - natrijev levotiroksinat

Euthyrox 150 mikrogramov tablete Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

euthyrox 150 mikrogramov tablete

merck d.o.o. - natrijev levotiroksinat - tableta - natrijev levotiroksinat 150 µg / 1 tableta - natrijev levotiroksinat

Euthyrox 50 mikrogramov tablete Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

euthyrox 50 mikrogramov tablete

merck d.o.o. - natrijev levotiroksinat - tableta - natrijev levotiroksinat 50 µg / 1 tableta - natrijev levotiroksinat

Euthyrox 25 mikrogramov tablete Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

euthyrox 25 mikrogramov tablete

merck d.o.o. - natrijev levotiroksinat - tableta - natrijev levotiroksinat 25 µg / 1 tableta - natrijev levotiroksinat

Natrijev levotiroksinat Norpharm Regulatory Services 100 mikrogramov/ 5 ml Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

natrijev levotiroksinat norpharm regulatory services 100 mikrogramov/ 5 ml

norpharm regulatory services ltd - natrijev levotiroksinat - peroralna raztopina - natrijev levotiroksinat 100 µg / 100 ml - natrijev levotiroksinat

Natrijev levotiroksinat Norpharm Regulatory Services 50 mikrogramov/ 5 ml Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

natrijev levotiroksinat norpharm regulatory services 50 mikrogramov/ 5 ml

norpharm regulatory services ltd - natrijev levotiroksinat - peroralna raztopina - natrijev levotiroksinat 50 µg / 100 ml - natrijev levotiroksinat

Afinitor Evropska unija - slovenščina - EMA (European Medicines Agency)

afinitor

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastična sredstva - hormon-receptor-pozitivno napredno prsi cancerafinitor je primerna za zdravljenje hormon-receptor-pozitiven, her2/neu-negativne napredno raka na dojki, v kombinaciji z exemestane, v post-menopavzi, brez simptomatsko visceralne bolezni po ponovitev ali napredovanje po nesteroidna zaviralec aromataze. neuroendocrine tumorji trebušne slinavke originafinitor je primerna za zdravljenje unresectable ali metastatskim, dobro ali zmerno diferenciran neuroendocrine tumorji trebušne slinavke izvora pri odraslih z progresivna bolezen,. neuroendocrine tumorji iz prebavil ali pljuč originafinitor je primerna za zdravljenje unresectable ali metastatskim, dobro diferencirana (razred 1 ali razred 2) ne-funkcionalne neuroendocrine tumorji iz prebavil ali pljuč izvora pri odraslih z progresivna bolezen,. ledvične celice carcinomaafinitor je indiciran za zdravljenje bolnikov z napredovalim ledvičnim-cell carcinoma, katerih bolezen je napredovala na ali po zdravljenju z vegf-usmerjena terapija.

Cabometyx Evropska unija - slovenščina - EMA (European Medicines Agency)

cabometyx

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastična sredstva - 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.