Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

koncentrat za raztopino za infundiranje - cisplatin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

raztopina za injiciranje - cisplatin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

b. braun melsungen ag - glicin; glutaminska kislina; histidin; alanin; arginin; asparaginska kislina; cistein; fenilalanin; izolevcin; levcin; lizin; metionin; prolin; serin; tirozin; treonin; triptofan; valin; tavrin - raztopina za infundiranje - glicin 2 mg / 1 ml  glutaminska kislina9,3 mg / 1 ml  histidin4,6 mg / 1 ml  alanin15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; glutaminska kislina 9,3 mg / 1 ml  histidin4,6 mg / 1 ml  alanin15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; histidin 4,6 mg / 1 ml  alanin15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; alanin 15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; arginin 9,1 mg / 1 ml  asparaginska ki - aminokisline

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

b. braun melsungen ag - glicin; glutaminska kislina; histidin; alanin; arginin; asparaginska kislina; cistein; fenilalanin; izolevcin; levcin; lizin; metionin; prolin; serin; tirozin; treonin; triptofan; valin; tavrin - raztopina za infundiranje - glicin 2 mg / 1 ml  glutaminska kislina9,3 mg / 1 ml  histidin4,6 mg / 1 ml  alanin15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; glutaminska kislina 9,3 mg / 1 ml  histidin4,6 mg / 1 ml  alanin15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; histidin 4,6 mg / 1 ml  alanin15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; alanin 15,9 mg / 1 ml  arginin9,1 mg / 1 ml  asparaginska kislina6,6 mg / 1 ml  cistein0,52 mg / 1 ml  fenilalanin3,1 mg / 1 ml  izolevcin5,1 mg / 1 ml  levcin7,6 mg / 1 ml  lizin8,8 mg / 1 ml  metionin2 mg / 1 ml  prolin6,1 mg / 1 ml  serin2 mg / 1 ml  tirozin1,06 mg / 1 ml  treonin5,1 mg / 1 ml  triptofan4 mg / 1 ml  valin6,1 mg / 1 ml  tavrin0,3 mg / 1 ml; arginin 9,1 mg / 1 ml  asparaginska ki - aminokisline

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - 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 - antineoplastična sredstva - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck europe b.v. - avelumab - neuroendokrine tumorje - druga zdravila z delovanjem na novotvorbe agenti, monoklonalna protitelesa - zdravilo bavencio je indicirano za samostojno zdravljenje odraslih bolnikov z metastatskim karcinomom merkelove celice (mcc). bavencio v kombinaciji z axitinib je določen za prvo linijo za zdravljenje odraslih bolnikov z napredovalim karcinomom ledvičnih (rkc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karcinoma, squamous cell - antineoplastična sredstva - 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.

Evropska unija - slovenščina - 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 - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - karcinom, pljučni pljuč - antineoplastična sredstva - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastična sredstva - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.