Unione Europea - italiano - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tubercolosi, resistente ai farmaci multiresistenti - antimicobatterici - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 e 5. dovrebbero essere prese in considerazione le linee guida ufficiali sull'uso appropriato degli agenti antibatterici..

Unione Europea - italiano - EMA (European Medicines Agency)

csl behring gmbh - immunoglobulina umana normale (scig) - sindromi da immunodeficienza immunologica - sieri immuni e immunoglobuline, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Unione Europea - italiano - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influenza, umano - antivirali per uso sistemico - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Unione Europea - italiano - EMA (European Medicines Agency)

dynavax gmbh - antigene di superficie dell'epatite b. - epatite b - vaccini - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Unione Europea - italiano - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - farmaci usati nel diabete - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 e 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Unione Europea - italiano - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - blocco neuromuscolare - tutti gli altri prodotti terapeutici - inversione del blocco neuromuscolare indotto da rocuronio o vecuronio. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Unione Europea - italiano - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vaccini - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.

Unione Europea - italiano - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - sugammadex sodium - blocco neuromuscolare - tutti gli altri prodotti terapeutici - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Unione Europea - italiano - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasi - immunosoppressori - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Unione Europea - italiano - EMA (European Medicines Agency)

biofrontera bioscience gmbh - 5-aminolevulinico acido cloridrato - keratosis, actinic; carcinoma, basal cell - agenti antineoplastici - trattamento delle cheratosi attiniche di gravità da lieve a moderata sul viso e sul cuoio capelluto (olsen grado 1 a 2; si veda la sezione 5. 1) e del campo di cancerizzazione negli adulti. trattamento superficiale e/o il carcinoma basocellulare nodulare inadatto per il trattamento chirurgico a causa di possibili correlati al trattamento di morbilità e/o di scarsa risultato cosmetico negli adulti.