Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hidroklorid - multiplo sklerozo, recidivno-nakazila - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 in 5. 1)orpatients s hitro razvijajočimi se hudo recidivno nakazila multiplo sklerozo, opredeljeno z 2 ali več onemogočanje zagonov v enem letu, in z 1 ali več gadolinium krepitev poškodbe na možganih, mri ali znatno povečanje t2 lezije obremenitvi, kot je v primerjavi s predhodnim zadnjih mri.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hidroklorid - multiplo sklerozo, recidivno-nakazila - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 in 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Evropska unija - slovenščina - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - vsi drugi terapevtski izdelki - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed ditromethamine - carcinoma, non-small-cell lung; mesothelioma - folna kislina analogi, antimetabolites - maligni pleural mesotheliomapemetrexed hospira uk limited v kombinaciji z cisplatin je primerna za zdravljenje kemoterapija naivna bolnikih z unresectable maligni pleural mesothelioma. non-small cell lung cancerpemetrexed hospira uk limited v kombinaciji z cisplatin je določen za prvo linijo zdravljenja bolnikov z lokalno napredno ali metastatskim non-small cell lung cancer razen pretežno skvamoznih celic histologija (glejte povzetek glavnih značilnosti zdravila oddelek 5. pemetrexed hospira uk limited, ki je označeno kot monotherapy za vzdrževanje zdravljenje lokalno napredno ali metastatskim non-small cell lung cancer razen pretežno skvamoznih celic histologijo pri bolnikih, katerih bolezen ni napredovala takoj po platinum, ki temelji kemoterapijo (glejte povzetek glavnih značilnosti zdravila oddelek 5. pemetrexed hospira uk limited, ki je označeno kot monotherapy za drugega-line zdravljenje bolnikov z lokalno napredno ali metastatskim non-small cell lung cancer razen pretežno skvamoznih celic histologija (glejte povzetek glavnih značilnosti zdravila oddelek 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - abirateron acetat - prostatične neoplazme - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Evropska unija - slovenščina - EMA (European Medicines Agency)

immunomedics gmbh - sulesomab - osteomyelitis; radionuclide imaging - diagnostični agenti - to zdravilo je samo za diagnostično uporabo. leukoscan je označen za diagnostično slikanje za določanje lokacije in obseg okužba/vnetje v kosti pri bolnikih z domnevno osteomielitis, vključno z bolniki z diabetično stopalo razjede. leukoscan ni bila zaposlena za ugotavljanje osteomielitisa pri bolnikih z anemija srpastih celic anemija.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - lamivudin - hepatitis b, kronični - antivirusi za sistemsko uporabo - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. začetek lamivudine zdravljenje je treba upoštevati le,, ko je uporaba alternativnih protivirusno uslužbenec z višjo genetske ovira ni na voljo ali je to primerno;, decompensated bolezni jeter v kombinaciji z drugo agent brez navzkrižno odpornost na lamivudine.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromide, indacaterol (acetate), mometasone furoate - astma - zdravila za obstruktivne pljučne bolezni, - maintenance treatment of asthma in adults whose disease is not adequately controlled.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - bolezen tipa ii za shranjevanje glikogena - drugi proizvodi prebavnega trakta in metabolizma - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).

Slovenija - slovenščina - Ecolab

ecolab deutschland gmbh -