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

eli lilly farmacevtska druŽba, d.o.o. - vehikel - prašek in vehikel za raztopino za injiciranje - vehikel 3,17 ml / 1 vložek - somatropin

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

eli lilly farmacevtska druŽba, d.o.o. - somatropin, rekombinantni - prašek in vehikel za raztopino za injiciranje - somatropin, rekombinantni 24 mg / 1 vložek - somatropin

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

tableta - alendronska kislina

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

tableta - alendronska kislina

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

filmsko obložena tableta s podaljšanim sproščanjem - indapamid

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

filmsko obložena tableta s podaljšanim sproščanjem - indapamid

Unione Europea - sloveno - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - docetaksel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastična sredstva - prsi cancerdocetaxel kabi v kombinaciji z doxorubicin in ciklofosfamid je primerna za adjuvant zdravljenje bolnikov z:v primerih, node-pozitivnega raka dojk;v primerih, node-negativne raka dojk. za bolnike z upravljajo node-negativne raka na dojki, adjuvant zdravljenje mora biti omejena na bolnike upravičeni do kemoterapijo v skladu z mednarodno uveljavljena merila za primarno zdravljenje zgodnjega raka dojke. docetaxel kabi v kombinaciji z doxorubicin je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke, ki pred tem še niso prejele citotoksična terapija za to stanje. docetaxel kabi monotherapy je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična terapija. predhodna kemoterapija je morala vključevati antraciklin ali sredstvo za alkiliranje. docetaxel kabi v kombinaciji z trastuzumab je indiciran za zdravljenje bolnikov z metastatskim rakom dojke, katerih tumorji, overexpress her2 in ki predhodno še niso prejeli kemoterapijo za metastatskim bolezni. docetaxel kabi v kombinaciji z capecitabine je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična kemoterapija. predhodno zdravljenje bi moralo vključiti antraciklin. non-small-cell lung cancerdocetaxel kabi je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskim non-small-cell lung cancer po izpadu pred kemoterapijo. docetaxel kabi v kombinaciji z cisplatin je indiciran za zdravljenje bolnikov z unresectable, lokalno napredno ali metastatskim non-small-celice pljučnega raka, pri bolnikih, ki pred tem še niso prejele kemoterapijo za to stanje. prostate cancerdocetaxel kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. docetaxel kabi v kombinaciji z androgen-pomanjkanje terapija (adt), z ali brez prednizon ali prednizolon, je indiciran za zdravljenje bolnikov z metastatskim hormonsko občutljivih raka prostate. Želodčni adenocarcinomadocetaxel kabi v kombinaciji z cisplatin in 5-fluorouracil je indiciran za zdravljenje bolnikov z metastatskim želodca, adenokarcinom, vključno z adenokarcinom v gastroezofagealna križišču, ki ga še niso prejeli pred kemoterapijo za metastatskim bolezni. glave in vratu cancerdocetaxel kabi v kombinaciji z cisplatin in 5-fluorouracil je primerna za indukcijsko zdravljenje bolnikov z lokalno napredno skvamoznih celic karcinom glave in vratu,.

Unione Europea - sloveno - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovarijske neoplazme - antineoplastična sredstva - ciste na cancerlynparza je označen kot monotherapy za:vzdrževanje zdravljenje odraslih bolnikov z napredovalim (figo fazah iii in iv) brca1/2-mutiral (germline in/ali somatski) high-grade epitelnih jajčnikov, fallopian tube ali primarni trebušno raka, ki so v odziv (popolna ali delna) po koncu prve vrstice platinum, ki temelji kemoterapijo. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 in 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. bolniki morajo imeti predhodno že bili zdravljeni z anthracycline in taxane v (neo)adjuvant ali metastatskim nastavitev, če bolniki niso bili primerni za temi postopki (glej točko 5. bolniki z hormon receptorjev (hr)-pozitivnega raka dojk, je treba tudi napredovala na ali po predhodnem endokrine terapije, ali neprimerna za endokrine terapija. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Unione Europea - sloveno - EMA (European Medicines Agency)

sandoz gmbh - rituksimab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastična sredstva - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. samo omejeni so na voljo podatki o učinkovitosti in varnosti za bolnike predhodno zdravljenih z monoklonalna protitelesa, vključno z rituksimabom ali bolniki, ognjevzdržni, da prejšnji rituksimabom plus kemoterapijo. glej oddelek 5. 1 za nadaljnje informacije. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituksimabom je dokazano, da zmanjša stopnjo napredovanja skupno škodo, merjeno z x-ray in izboljšati telesno funkcijo, če bi imeli v kombinaciji z metotreksatom. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

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

generics (uk) ltd. - flutikazonpropionat, salmeterol - inhalacijska suspenzija pod tlakom - flutikazonpropionat 250 µg / 1 odmerek; salmeterol 25 µg / 1 odmerek - salmeterol in flutikazon