Gazyvaro Euroopan unioni - sloveeni - EMA (European Medicines Agency)

gazyvaro

roche registration gmbh - obinutuzumab - levkemija, limfocitna, kronična, b-celica - antineoplastična sredstva - kronično limfocitno levkemijo (cll)gazyvaro v kombinaciji z chlorambucil je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih kronično limfocitno levkemijo (cll) in z comorbidities česar so neprimerni za celoten odmerek fludarabine temelji terapije (glejte poglavje 5. folikularni limfom (fl)gazyvaro v kombinaciji s kemoterapijo, sledi gazyvaro vzdrževanje terapije pri pacientih, ki so dosegli odziv, ki je primerna za zdravljenje bolnikov s predhodno nezdravljenih napredno folikularni limfom. gazyvaro v kombinaciji z bendamustine sledi gazyvaro vzdrževanje je indiciran za zdravljenje bolnikov z folikularni limfom (fl), ki niso odzvali ali kdo napredoval med ali do 6 mesecev po zdravljenju z rituksimabom ali rituksimabom, ki vsebujejo režim.

Nuedexta Euroopan unioni - sloveeni - EMA (European Medicines Agency)

nuedexta

jenson pharmaceutical services limited - dextromethorphan, quinidine - nevrološke manifestacije - druga zdravila na živčnem sistemu - zdravilo nuedexta je indicirano za simptomatsko zdravljenje pseudobulbarnega vpliva (pba) pri odraslih. učinkovitost so raziskali samo pri bolnikih z osnovno amiotrofično lateralno sklerozo ali multiplo sklerozo.

Dimethyl fumarate Neuraxpharm Euroopan unioni - sloveeni - EMA (European Medicines Agency)

dimethyl fumarate neuraxpharm

laboratorios lesvi s.l. - dimetil fumarat - multiplo sklerozo, recidivno-nakazila - imunosupresivi - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Teriflunomide Mylan Euroopan unioni - sloveeni - EMA (European Medicines Agency)

teriflunomide mylan

mylan pharmaceuticals limited - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Quofenix Euroopan unioni - sloveeni - EMA (European Medicines Agency)

quofenix

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - okužbe, pridobljene v skupnosti - antibacterials za sistemsko uporabo, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.