Unione Europea - italiano - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosoppressori - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Unione Europea - italiano - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - infezioni da hiv - antivirali per uso sistemico - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Italia - italiano - Ministero della Salute

boehringer ingelheim animal health italia s.p.a - virus bronchite infettiva aviaria (ibv), tipo 793/b, ceppo cr88121, vivo - virus bronchite infettiva aviaria (ibv); tipo 793/b; ceppo cr88121; vivo - 4 log 10 eid 50 - dose infettante il 50% degli embrioni, virus vivi attenuati della bronchite infettiva aviare ceppo variante cr88121 - 10 elevato alla 4; 0 die50/dose - avian infectious bronchitis virus

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

moderna switzerland gmbh - elasomeranum - injektionsdispersion - elasomeranum 1.26 mg, heptadecan-9-ylis 8-((2-hydroxyethyl)(6-oxo-6-(undecyloxy)hexyl)amino)-octanoas, cholesterolum, 1,2-distearoyl-sn-glycero-3-phosphocholinum, 1,2-dimyristoyl-rac-glycero-3-polyethylenglycoli 2000 aether methylicus, trometamolum, trometamoli hydrochloridum, acidum aceticum, natrii acetas, saccharum, aqua ad iniectabile, ad suspensionem pro 6.3 ml corresp. natrium 0.033 mg pro dosi. - befristet zugelassene indikation: spikevax ist für die aktive immunisierung zur vorbeugung der durch das sars-cov-2-virus verursachten coronavirus-2019-erkrankung (covid-19) bei besonders gefährdeten kindern im alter von 6 monaten bis < 2 jahren indiziert.; regulär zugelassene indikation: spikevax ist für die aktive immunisierung zur vorbeugung der durch das sars-cov-2-virus verursachten coronavirus-2019-erkrankung (covid-19) bei personen ab 2 jahren indiziert. - vaccini

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

moderna switzerland gmbh - elasomeranum - injektionsdispersion - dispersion zur injektion: elasomeranum 0.05 mg pro dosi, elasomeranum für kinder ab 6 monate bis 5 jahre 0.025 mg pro dosi, heptadecan-9-ylis 8-((2-hydroxyethyl)(6-oxo-6-(undecyloxy)hexyl)amino)-octanoas, cholesterolum, 1,2-distearoyl-sn-glycero-3-phosphocholinum, 1,2-dimyristoyl-rac-glycero-3-polyethylenglycoli 2000 aether methylicus, trometamolum, trometamoli hydrochloridum, acidum aceticum glaciale, natrii acetas trihydricus, saccharum, aqua ad iniectabile, natrium 0.017 mg, pro dosi. - befristet zugelassene indikation: spikevax ist für die aktive immunisierung zur vorbeugung der durch das sars-cov-2-virus verursachten coronavirus-2019-erkrankung (covid-19) bei besonders gefährdeten kindern im alter von 6 monaten bis < 2 jahren indiziert.; regulär zugelassene indikation: spikevax ist für die aktive immunisierung zur vorbeugung der durch das sars-cov-2-virus verursachten coronavirus-2019-erkrankung (covid-19) bei personen ab 2 jahren indiziert. - vaccini

Italia - italiano - AIFA (Agenzia Italiana del Farmaco)

zentiva italia s.r.l. - bosentan - bosentan

Italia - italiano - AIFA (Agenzia Italiana del Farmaco)

mylan s.p.a. - bosentan - bosentan

Italia - italiano - Ministero della Salute

boehringer ingelheim animal health italia s.p.a - virus bronchite infettiva aviaria (ibv), tipo 793/b, ceppo cr88121, vivo - virus bronchite infettiva aviaria (ibv); tipo 793/b; ceppo cr88121; vivo - 4 log 10 eid 50 - dose infettante il 50% degli embrioni, virus vivi attenuati della bronchite infettiva aviare ceppo variante cr88121 - 4.6 eid 50/dose, virus vivi attenuati della bronchite infettiva aviare ceppo variante cr88121 - 10 elevato alla 4; 0 eid50/dose - avian infectious bronchitis virus

Italia - italiano - Ministero della Salute

boehringer ingelheim animal health italia s.p.a - vaccino colibacillosi neonatale inattivato per i ruminanti + vaccino coronavirosi bovina inattivato + vaccino rotavirosi bovina inattivato - iniettabile - vaccino colibacillosi neonatale inattivato per i ruminanti + vaccino coronavirosi bovina inattivato + vaccino rotavirosi bovina inattivato - immunologici per bovini - vitelli - prevenzione delle affezioni neonatali da escherichia coli, rotavirus e coronavirus dei vitelli attraverso la vaccinazione della vacca gestante.

Italia - italiano - AIFA (Agenzia Italiana del Farmaco)

hameln pharma gmbh - desametasone - desametasone