Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomid - multiple myeloma - imunosupresivi - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide sebe v kombinaciji z dexamethasone je primerna za zdravljenje več plazmocitom pri odraslih bolnikih, ki so prejeli vsaj en pred terapijo. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakonazol - mycoses - antimikotiki za sistemsko uporabo - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. posaconazole soglasju navede tudi za profilaksa invazivnih glivičnih okužb v naslednjih bolnikov: bolniki, ki prejemajo odpust-indukcijske kemoterapijo za akutno myelogenous levkemijo (aml) ali myelodysplastic sindromov (mds) pričakuje, da bo rezultat v daljšem neutropenia in pri katerih obstaja visoko tveganje za nastanek invazivnih glivičnih okužb;hematopoietic matičnih celic za presajanje (hsct) prejemniki, ki so v visoki odmerki imunosupresivna terapija za cepljene (graft versus host disease in pri katerih obstaja visoko tveganje za nastanek invazivnih glivičnih okužb,.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron acetat - prostatične neoplazme - endokrini terapija - abiraterone accord 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 indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 in 5. 1 za razpoložljive podatke o različnih kombinacijah).

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi, selektivno imunosupresivi - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Europeiska unionen - slovenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimetil fumarat - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Slovenien - slovenska - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

accord healthcare - irinotekan - koncentrat za raztopino za infundiranje - irinotekan 17,33 mg / 1 ml - irinotekan

Slovenien - slovenska - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

accord healthcare - irinotekan - koncentrat za raztopino za infundiranje - irinotekan 17,33 mg / 1 ml - irinotekan

Slovenien - slovenska - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

accord healthcare - irinotekan - koncentrat za raztopino za infundiranje - irinotekan 17,33 mg / 1 ml - irinotekan

Slovenien - slovenska - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

accord healthcare - irinotekan - koncentrat za raztopino za infundiranje - irinotekan 17,33 mg / 1 ml - irinotekan