Slovenia - sloveeni - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

gruenenthal gmbh - tapentadol - tableta s podaljšanim sproščanjem - tapentadol 250 mg / 1 tableta - tapentadol

Slovenia - sloveeni - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

gruenenthal gmbh - tapentadol - tableta s podaljšanim sproščanjem - tapentadol 150 mg / 1 tableta - tapentadol

Slovenia - sloveeni - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

gruenenthal gmbh - tapentadol - tableta s podaljšanim sproščanjem - tapentadol 50 mg / 1 tableta - tapentadol

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. v kombinaciji z bortezomib, thalidomide in dexamethasone za zdravljenje odraslih bolnikov z na novo prijavljenih več plazmocitom, ki so upravičeni do autologous matičnih celic za presajanje. v kombinaciji z lenalidomide in dexamethasone, ali bortezomib in dexamethasone, za zdravljenje odraslih bolnikov z več plazmocitom, ki so prejeli vsaj en pred terapijo. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. kot monotherapy za zdravljenje odraslih bolnikov z relapsed in ognjevzdržne več plazmocitom, katerih predhodno zdravljenje vključeni proteasome serotonina in imunomodulatornimi agent in ki so pokazali napredovanja bolezni na zadnji terapija. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

janssen-cilag international nv - etravirine - okužbe z virusom hiv - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, v kombinaciji z inhibitor proteaz povečala in drugih protiretrovirusna zdravila, je indicirano za zdravljenje okužbe ljudi-imunske pomanjkljivosti-virus-tipa 1 (hiv-1) v doživeli protiretrovirusno zdravljenje odraslih bolnikov in v protiretrovirusno zdravljenje, izkušeni pediatrični bolniki iz šestih let. ta navedba temelji na teden-48 analize iz dveh faza-iii preskušanj v zelo pretreated bolnikih, kjer intelence je v preiskavi v kombinaciji z optimalnim ozadju režim (obr), ki je vključevala darunavir/ritonavir. navedba v pediatričnih bolnikih, ki temelji na 48-tedensko analiz eno roko, faza ii sojenja v protiretrovirusno zdravljenje z izkušenimi pediatričnih bolnikih.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

janssen-cilag international nv - paliperidon - schizophrenia; psychotic disorders - psiholeptiki - zdravilo invega je indicirano za zdravljenje shizofrenije pri odraslih in pri mladostnikih, starih 15 let ali več. invega je primerna za zdravljenje schizoaffective motnje pri odraslih.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

janssen-cilag international nv - kanaglifozin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidon palmitat - shizofrenija - psiholeptiki - zdravilo xeplion je indicirano za vzdrževalno zdravljenje shizofrenije pri odraslih bolnikih, stabiliziranih z paliperidonom ali risperidonom. in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

janssen-cilag international n.v. - abirateron acetat - prostatične neoplazme - endokrini terapija - zytiga je označena z prednizon ali prednizolon za:zdravljenje metastatskega kastracije odporne raka na prostati pri odraslih moških, ki so asimptomatsko ali lahko simptomatsko po okvari androgen odvzem terapije, pri katerih kemoterapijo še ni klinično indicatedthe zdravljenje metastatskega kastracije odporne raka na prostati pri moških odraslih, katerih bolezen je napredovala na ali po docetaxel temelji kemoterapijo režim.