България - български - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v. - bovilis герпесвирусу тип 1(|БХВ - 1), на живо, щам gc/Д (fe-) - лиофилизат и разтворител за инжекционна суспензия - мин. 10 на степен 5.7 – мак. 10 на степен 7.3 tcid50 - говеда

Европейски съюз - български - EMA (European Medicines Agency)

intervet international bv - ваксина срещу вируса на болестта син език, серотип 8 (инактивиран) - Инактивированные вирусни ваксини, вирусът блютанга, овце - sheep; cattle - cattle to stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia sheep to stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia,.

Европейски съюз - български - EMA (European Medicines Agency)

intervet international b.v. - ваксина срещу вируса на болестта син език, серотип 8 (инактивиран) - Имунологични препарати за овце - cattle; sheep - sheepfor активна имунизация овце от 2. 5-месечна възраст за предотвратяване на виремията * и за намаляване на клиничните признаци, причинени от вируса на син език, серотип 8. cattlefor активна имунизация на едрия рогат добитък от 2. 5-месечна възраст за предотвратяване на виремия *, причинена от вируса на син език, серотип 8. * (Стойност на цикъл (ct) ≥ 36 чрез валидиран rt-pcr метод, показващ липса на вирусен геном).

България - български - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v. - Респираторно-синцитиальный вирус от едър рогат добитък (brsv), прецедете jencine-2013; видео; parainfluenza virus тип 3 говеждо месо (ПИ3), прецедете int2-2013, видео - Спрей за нос, лиофилизат и разтворител за суспензия за интраназално приложение - 5.0 – 7.0 log10 tcid50; 4.8 – 6.5 log10 tcid50 - говеда

България - български - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v. - Ротавирус, едър рогат добитък, инактивированной, щам Великобритания-Комптън, серотип g6 и p5; коронавируса, едър рогат добитък, инактивированной, щам mebus; е. коли клавиша f5 (в k99) адгезиного - инжекционна суспензия - ¼ dose of vaccine stimulates a virus neutralising antibody titre ≥ 7.7 log2/ml (guinea pigs); 1/20 dose of vaccine stimulates an elisa antibody titre ≥ 3.41 log10/ml (guinea pigs); 1/20 dose of vaccine stimulates an elisa antibody (od492) > 0.64 (gui - говеда

България - български - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v - Респираторно-синцитиальный вирус от едър рогат добитък (brsv), нига., щам ev908, parainfluenza-3 вирусни, Инак., щам sp-4 Райзингер, mannheimia (бактерии, pasteurella) haemolytica setotype А1, Инак., щам m4/1 - инжекционна суспензия - най-малко 10 на степен 5, 5 tcid50 - най-много 10 на степен 6, 4 tcid50; най-малко 10 на степен 7, 3 tcid50 - най-много 10 на ст - говеда

България - български - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v. - 50 единици на ifa бича на вирусна диария (bvdv), нига., щам с-86 - инжекционна суспензия - ≥ 4, 6 log 2 vn единици - говеда

България - български - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v. - Герпесвирус едър рогат добитък - 1 (БХВ-1) kye, инактивированная antigenstrain щам gc/Д - инжекционна суспензия - 60 elisa единици за индуциране на 6, 1 - 11,1 log2 vn единици - говеда

България - български - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v - Трихофитон verrucosum, спокойна, щам ЛТФ-130 - лиофилизат и разтворител за инжекционна суспензия - ≥ 9 х 10 на 6 степен ≤ 21 х 10 на 6 степен жизнеспособни микроконидии - говеда

Европейски съюз - български - 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 - Антинеопластични средства - 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.