Unjoni Ewropea - Litwanjan - 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.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

inceptua ab - paklitakselis - kiaušidžių navikai - antineoplastic agents, taxanes - apealea kartu su carboplatin fluorouracilu ir folino suaugusių pacientų su pirma atkryčio platinos‑jautrus epitelinis kiaušidžių vėžys, pirminės pilvaplėvės vėžys ir kiaušintakių vėžiu.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

vétoquinol sa - emodepside, praziquantel, tigolaner - vaistai nuo kirmėlių, - katės - for cats with, or at risk from, mixed parasitic infestations. the veterinary medicinal product is exclusively indicated when ectoparasites, cestodes and nematodes are targeted at the same time.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

dechra regulatory b.v. - mirtazapine - psychoanaleptics, antidepressants in combination with psycholeptics - katės - dėl kūno svorio padidėjimas katės patiria prastas apetitas ir svorio nuostolius, nuo lėtinių ligų.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - kapecitabinas - kolorektaliniai navikai - antinavikiniai vaistai - capecitabine medac skiriamas adjuvantiniam pacientų gydymui po iii stadijos (dukes'o stadijos c) kiaušidžių vėžio operacijos. capecitabine medac fluorouracilu ir folino metastazavusiu kolorektaliniu vėžiu. capecitabine medac yra nurodyta pirmos eilės gydymas papildomi skrandžio vėžys, derinant su platinos pagrindu režimas. capecitabine medac kartu su docetaxel skiriamas pacientams, sergantiems lokaliai išplitusio arba metastazavusio krūties vėžio, kai sugenda citotoksinės chemoterapijos. ankstesnėje terapijoje reikėjo įtraukti antracikliną. capecitabine medac yra taip pat nurodė, kaip monotherapy gydomi pacientai su lokaliai išplitusio arba metastazavusio krūties vėžio, kai sugenda taxanes ir pasirinkusios gydymą antraciklinų-kurių sudėtyje chemoterapijos kursu ar kam dar pasirinkusios gydymą antraciklinų terapijos nenurodytas.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

cz veterinaria s.a. - bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated] - imunologiniai preparatai - sheep; cattle - sheepactive vakcinacijos nuo mėlynojo liežuvio ligos viruso serotipas 8 išvengti viraemia ir sumažinti klinikinius požymius. imuniteto pradžia: 20 dienų po antrosios dozės. imuniteto trukmė: 1 metai po antrosios dozės. cattleactive vakcinacijos nuo mėlynojo liežuvio ligos viruso serotipas 8 išvengti viraemia. imuniteto atsiradimas: 31 diena po antrosios dozės. imuniteto trukmė: 1 metai po antrosios dozės.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

zoetis belgium sa - inaktyvuotas vakarų nilo virusas, vm-2 padermė - arklinių šeimos gyvūnų imunologai - arkliai - norint aktyviai imunizuoti šešių mėnesių ar vyresnius arklius prieš vakarų-nilo viruso ligą, sumažinant viraeminių žirgų skaičių.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - imunologiniai vaisiai suidae - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. kitas svarbus veiksnys, skatinantis kiaules, yra skatolis, taip pat gali būti sumažintas kaip netiesioginis poveikis. taip pat sumažėja agresyvus ir seksualinis (montavimas) elgesys. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - vakarų nilo rekombinantinis canarypox virusas (vcp2017 virusas) - immunologicals arklinių šeimos gyvūnų, arklių, immunologicals - arkliai - aktyvios imunizacijos arklius, nuo penkių mėnesių amžiaus nuo vakarų nilo ligų skaičiaus mažinimas viraemic arkliai. jei yra klinikinių požymių, jų trukmė ir sunkumas yra mažesni.

Unjoni Ewropea - Litwanjan - EMA (European Medicines Agency)

eli lilly and company limited - spinosadas, milbemycin oxime - nėra vaistai, insekticidai ir repelentai, endectocides - Šunys - gydymo ir prevencijos nuo blusų (ctenocephalides felis) invazijos šunys, kai viena ar daugiau iš šių požymių, privalo kartu: prevencija heartworm ligos (l3, l4 dirofilaria immitis);prevencijos angiostrongylosis sumažinti infekcijos lygį su nesubrendęs suaugusiųjų (l5) angiostrongylus vasorum;virškinamojo trakto nematodas infekcijų, kurias sukelia hookworm (l4, nesubrendęs suaugusiųjų, l5) ir suaugusiųjų ancylostoma caninum), apvaliųjų kirmėlių (nesubrendusių suaugusiųjų l5, ir suaugusiųjų toxocara canis ir suaugusiųjų toxascaris leonina) ir whipworm (suaugusiųjų trichuris vulpis).