Europska Unija - hrvatski - EMA (European Medicines Agency)

zoetis belgium sa - virus kuge mesožderke, soj ЦДВ bio 11/a, pasji аденовируса tipa 2, soj kav-2 bio 13, parvovirus pasa tip 2b, procijediti cpv-2b bio 12/b, pas парагриппа tipa 2, virusa, soj cpiv-2 bio 15 (sve žive аттенуированные), interrogans серовара лептоспир серогруппы Аустралис bratislava, procijediti mslb 1088, l. interrogans серогруппы icterohaemorrhagiae серовар icterohaemorrhagiae, procijediti mslb 1089, l. interrogans серогруппы Кашницкого серовара Кашницкого, procijediti mslb 1090, l. kirschneri серогруппы grippotyphosa серовара grippotyphosa, procijediti mslb 1091... - živjeti kuge mesožderke virus + video pseću аденовирус + video psa парагриппа virus + video parvovirus pasa + инактивированные лептоспиры, imunomodulatori za псовые - psi - aktivna imunizacija pasa sa 6 tjedana starosti:kako bi se spriječilo smrtnosti i kliničkih simptoma uzrokovanih virusom kuge mesožderke,kako bi se spriječilo smrtnosti i kliničkih znakova, uzrokovane pas аденовируса tipa 1,za sprečavanje kliničkih simptoma i smanjenje zaraze izlučivanje uzrokovane pas аденовируса tipa 2,kako bi se spriječilo kliničkih znakova, leucopoenia i virusne izlučivanje uzrokovane parvo pasa,kako bi se spriječilo kliničke manifestacije (nosni i očni iscjedak) i smanjenje zaraze izlučivanje uzrokovane pas парагриппа virus,kako bi se spriječilo klinički znakovi infekcije mokraćnog izlučivanje uzrokovana l. interrogans серогруппы Аустралис серовара bratislava,kako bi se spriječilo kliničkih znakova i izlučivanje urina i smanjuju infekcije uzrokovane l. interrogans serotip canicola serovar canicola i l. interrogans serotip icterohaemorrhagiae serovar icterohaemorrhagiae i za sprečavanje kliničkih znakova i smanjenje infekcije i izlučivanje urina uzrokovanih l. interrogans serogroup grippotyphosa serovar grippotyphosa.

Europska Unija - hrvatski - EMA (European Medicines Agency)

zoetis belgium sa - virus kuge mesožderke, soj ЦДВ bio 11/a, pasji аденовируса tipa 2, soj kav-2 bio 13, parvovirus pasa tip 2b, procijediti cpv-2b bio 12/b, pas парагриппа tipa 2, virusa, soj cpiv-2 bio 15 (sve žive аттенуированные), interrogans серовара лептоспир серогруппы Аустралис bratislava, procijediti mslb 1088, l. interrogans серогруппы icterohaemorrhagiae серовар icterohaemorrhagiae, procijediti mslb 1089, l. interrogans серогруппы Кашницкого серовара Кашницкого, procijediti mslb 1090, l. kirschneri серогруппы grippotyphosa серовара grippotyphosa, procijediti mslb 1091... - živjeti kuge mesožderke virus + video pseću аденовирус + video parainfl.virus + video parvovirus pasa + инактивированной антирабической + инактивированные лептоспиры, imunomodulatori za псовые - psi - aktivna imunizacija pasa sa 8-9 tjedana starosti:kako bi se spriječilo smrtnosti i kliničkih simptoma uzrokovanih virusom kuge mesožderke,kako bi se spriječilo smrtnosti i kliničkih znakova, uzrokovane pas аденовируса tipa 1,za sprečavanje kliničkih simptoma i smanjenje zaraze izlučivanje uzrokovane pas аденовируса tipa 2,kako bi se spriječilo kliničkih znakova, leucopoenia i virusne izlučivanje uzrokovane parvo pasa,kako bi se spriječilo kliničke manifestacije (nosni i očni iscjedak) i smanjenje zaraze izlučivanje uzrokovane pas парагриппа virus,kako bi se spriječilo klinički znakovi infekcije mokraćnog izlučivanje uzrokovana l. interrogans серогруппы Аустралис серовара bratislava,kako bi se spriječilo kliničkih znakova i izlučivanje urina i smanjuju infekcije uzrokovane l. interrogans serotip canicola serovar canicola i l. interrogans серогруппы icterohaemorrhagiae icterohaemorrhagie серовара,kako bi se spriječilo kliničkih znakova i smanjenje infekcija i mokraćnog uzrokovana l. interrogans serogroupa grippotyphosa serovar grippotyphosa i za sprečavanje smrtnosti, kliničkih znakova i infekcije uzrokovanih virusom bjesnoće.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

actavis group ptc ehf - pemetreksidni dikisid monohidrat - carcinoma, non-small-cell lung; mesothelioma - antineoplastična sredstva - kancerogen плевральный mesotheliomapemetrexed u kombinaciji s цисплатином indiciran za liječenje naivne kemoterapije u bolesnika s operirati raka mesothelioma плевры. Немелкоклеточного pluća cancerpemetrexed u kombinaciji s цисплатином indiciran za prvu liniju terapije bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией. Пеметрексед prikazan kao monoterapija za liječenje местнораспространенного ili метастатического немелкоклеточного raka pluća, druge, nego pretežno плоскоклеточного гистологии kod pacijenata, bolest kojoj se ne прогрессировало odmah nakon kemoterapije платиносодержащей. Пеметрексед prikazan kao monoterapija za drugu liniju terapije kod bolesnika sa lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - Ипилимумаб - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastična sredstva - 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 i 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%.

Europska Unija - hrvatski - EMA (European Medicines Agency)

virbac s.a. - tulathromycin - antibakterijska sredstva za sistemsku uporabu - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liječenje ranih stadija infektivnog pododermitisa (trbuha nogu) povezanih s virulentnim dichelobacter nodosusom koji zahtijeva sustavno liječenje.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ceva santé animale - tulathromycin - antibakterijska sredstva za sistemsku uporabu - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liječenje ranih stadija infektivnog pododermitisa (trbuha nogu) povezanih s virulentnim dichelobacter nodosusom koji zahtijeva sustavno liječenje.

Europska Unija - hrvatski - EMA (European Medicines Agency)

elanco gmbh - tulathromycin - antibakterijska sredstva za sistemsku uporabu - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liječenje ranih stadija infektivnog pododermitisa (trbuha nogu) povezanih s virulentnim dichelobacter nodosusom koji zahtijeva sustavno liječenje.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vetoquinol - tulathromycin - antibakterijska sredstva za sistemsku uporabu - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liječenje ranih stadija infektivnog pododermitisa (trbuha nogu) povezanih s virulentnim dichelobacter nodosusom koji zahtijeva sustavno liječenje.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vmd n.v. - tulathromycin - antibacterials for systemic use, macrolides - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prisutnost bolesti u stadu treba biti uspostavljena prije metafilaktičkog liječenja. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liječenje ranih stadija infektivnog pododermitisa (trbuha nogu) povezanih s virulentnim dichelobacter nodosusom koji zahtijeva sustavno liječenje.