Opdivo Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

opdivo

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.

Yervoy Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antinavikiniai vaistai - 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 ir 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%.

Libtayo Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

libtayo

regeneron ireland designated activity company (dac) - cemiplimab - karcinoma, plazminė ląstelė - antinavikiniai vaistai - 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.

Imjudo Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

imjudo

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antinavikiniai vaistai - 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.

Tremelimumab AstraZeneca Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

tremelimumab astrazeneca

astrazeneca ab - tremelimumab - karcinoma, nesmulkiųjų ląstelių skausmas - antinavikiniai vaistai - tremelimumab astrazeneca 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.

Bavencio Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

bavencio

merck europe b.v. - avelumabas - neuroendokrininiai navikai - kiti antinavikiniai vaistai agentai, monokloniniai antikūnai, - bavencio yra monoterapija, skirta suaugusiems pacientams, sergantiems metastazavusia merkelio ląstelių karcinoma (mcc). bavencio kartu su axitinib yra nurodyta pirmos eilės gydymas suaugę pacientai, sergantys progresavusia inkstų ląstelių karcinoma (rbt). 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.

Ceprotin Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

ceprotin

takeda manufacturing austria ag - žmogaus proteinas c - purpura fulminans; protein c deficiency - antitromboziniai vaistai - ceprotin is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein c deficiency.

Melosus Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

melosus

cp-pharma handelsgesellschaft mbh - meloksikamas - raumenų ir skeleto sistemos - dogs; cats; guinea pigs - Šunys:mažinti uždegimą ir skausmą, ūmus ir lėtinis raumenų ir kaulų sistemos sutrikimų šunims. katės:mažinimui lengvas ar vidutinio sunkumo pooperacinį skausmą ir uždegimą, po chirurginių procedūrų katės, e. ortopedijos ir minkštųjų audinių chirurgija. palengvinti skausmą ir uždegimą lėtinio raumenų ir kaulų sistemos sutrikimų katės. jūrų kiaulytės:mažinimui lengvas ar vidutinio sunkumo pooperacinio skausmo, susijusios su minkštųjų audinių operacijos, pvz., vyrų kastracija.

Metacam Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

metacam

boehringer ingelheim vetmedica gmbh - meloksikamas - oxicams - horses; dogs; cattle; cats; pigs; guinea pigs - katės:mažinimui lengvas ar vidutinio sunkumo pooperacinį skausmą ir uždegimą, po chirurginių procedūrų, e. ortopedijos ir minkštųjų audinių chirurgija. palengvinti skausmą ir uždegimą, ūminis ir lėtinis raumenų ir kaulų sistemos sutrikimai. sumažinti pooperacinį skausmą po ovariohysterectomy ir nedideli minkštųjų audinių chirurgija. cattle:for use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. vartoti kartu su peroraliniu rehidracijos gydymu viduriu, kad sumažėtų klinikinių požymių daugiau kaip savaitės veršeliams ir jauniems, negyviems galvijams. pooperacinio skausmo reljefas po veršelių atsikabinimo. papildomam gydymui ūminio mastito gydymui kartu su antibiotikų terapija. dogs:alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. pooperacinio skausmo ir uždegimo sumažinimas po ortopedinių ir minkštųjų audinių operacijų. horses:for use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. dėl skausmo, susijusio su arklių kolikomis, reljefas. mažinti uždegimus ir skausmo malšinimo tiek ūmus ir lėtinis raumenų ir kaulų sistemos sutrikimai. kiaulės: naudoti neinfekcinių judėjimo sutrikimų, siekiant sumažinti simptomų lameness ir uždegimas. už pagalbą pooperacinio skausmo, susijusios su nedideli minkštųjų audinių chirurgija, tokių kaip kastracija. už adjunctive terapijos gydymo puerperal kraujo užkrėtimas ir toxaemia (karvių mastito-metrito-agalaktijos sindromas) su tinkama antibiotikų terapija. jūrų kiaulytės:mažinimui lengvas ar vidutinio sunkumo pooperacinio skausmo, susijusios su minkštųjų audinių operacijos, pvz., vyrų kastracija.

Rheumocam Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

rheumocam

chanelle pharmaceuticals manufacturing limited - meloksikamas - oxicams, anti-inflammatory and anti-rheumatic products, non-steroids - dogs; horses; cats; cattle; pigs - dogsalleviation uždegimas ir skausmas (ūmus ir lėtinis raumenų ir kaulų sistemos sutrikimų šunims. sumažinti pooperacinį skausmą ir uždegimą po ortopedinių ir minkštųjų audinių operacijų. catsreduction apie pooperacinį skausmą po ovariohysterectomy ir nedideli minkštųjų audinių chirurgija. palengvinimas lengvas ar vidutinio sunkumo pooperacinį skausmą ir uždegimą, po chirurginių procedūrų katės, e. ortopedijos ir minkštųjų audinių chirurgija. palengvinti skausmą ir uždegimą, ūminis ir lėtinis raumenų ir kaulų sistemos sutrikimų katės. cattlefor naudoti ūmios kvėpavimo takų infekcijos su tinkama antibiotikų terapija, siekiant sumažinti klinikinius požymius. vartoti kartu su peroraliniu rehidracijos gydymu viduriu, kad sumažėtų klinikinių požymių daugiau kaip savaitės veršeliams ir jauniems, negyviems galvijams. papildomam gydymui ūminio mastito gydymui kartu su antibiotikų terapija. pigsfor naudoti neinfekcinių judėjimo sutrikimų, siekiant sumažinti simptomų lameness ir uždegimas. už adjunctive terapijos gydymo puerperal kraujo užkrėtimas ir toxaemia (karvių mastito-metrito-agalaktijos sindromas) su tinkama antibiotikų terapija. pooperacinio skausmo, susijusio su nedideliu minkštuoju audiniu, tokiu kaip kastracija, reljefas. horsesalleviation uždegimui ir skausmui tiek ūmus ir lėtinis raumenų ir kaulų sistemos sutrikimų arkliai. dėl skausmo, susijusio su arklių kolikomis, reljefas.