Europos Sąjunga - lietuvių - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

novartis europharm limited - lapatinibas - krūties navikai - baltymų kinazės inhibitoriai - tyverb yra nurodyta, kad pacientų, sergančių krūties vėžiu, kurių augliai overexpress her2 (erbb2):kartu su capecitabine pacientams su išplitusio arba metastazavusio ligos progresavimo po prieš terapija, kuri turi būti įtraukta anthracyclines ir taxanes ir terapija su trastuzumab į metastazių nustatymas;kartu su trastuzumab pacientams su hormonų receptorių neigiamais metastazavusiu, kad liga progresavo dėl prieš trastuzumab terapijos ar gydymo procedūras kartu su chemoterapija;kartu su aromatazės inhibitorius, skirtas moterims po menopauzės su hormonų receptorių teigiamais metastazavusiu liga, šiuo metu nėra skirta chemoterapija. pacientų registracijos studijų anksčiau nebuvo gydomi trastuzumab ar aromatazės inhibitorius,. nėra duomenų apie efektyvumą, šis derinys, palyginti su trastuzumab kartu su aromatazės inhibitorius, šioje pacientų populiacijoje.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

pharma mar s.a. - trabektedinas - ovarian neoplasms; sarcoma - antinavikiniai vaistai - yondelis skirtas gydyti pacientams, sergantiems išplėstinė minkštųjų audinių sarkoma, po nesėkmingo antraciklinais ir ifosfamide, arba kurie nėra tinkami gauti šių veiksnių. veiksmingumo duomenys daugiausia grindžiami liposarkoma ir leiomyosarkoma sergantiems pacientams. yondelis kartu su pegylated liposomal doxorubicin (pld) skiriamas pacientams, sergantiems atsinaujino platinum-jautrus kiaušidžių vėžys.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

sanofi winthrop industrie - aflibercept - kolorektaliniai navikai - antinavikiniai vaistai - metastazavusio kolorektalinio vėžio gydymas (mcrc).

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

grindeks as - benzilbenzoatas - tepalas - 200 mg/g - benzyl benzoate

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

teva b.v. - docetakselis - koncentratas infuziniam tirpalui - 20 mg/ml - docetaxel

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

hospira uk limited - docetakselis - koncentratas infuziniam tirpalui - 10 mg/ml - docetaxel

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

teva pharma b.v. - folino rūgštis - injekcinis tirpalas - 10 mg/ml - calcium folinate

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

medac gesellschaft für klinische spezialpräparate mbh - mitomicinas - milteliai šlapimo pūslės tirpalui ar injekciniam tirpalui - 1 mg/ml - mitomycin

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

teva b.v. - acitretinas - kietosios kapsulės - 10 mg - acitretin