Tecentriq Evropska unija - slovenščina - EMA (European Medicines Agency)

tecentriq

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastična sredstva - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq kot monotherapy je indiciran za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim nsclc po predhodno kemoterapijo. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq kot monotherapy je indiciran za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim nsclc po predhodno kemoterapijo. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Enspryng Evropska unija - slovenščina - EMA (European Medicines Agency)

enspryng

roche registration gmbh - satralizumab - neuromyelitis optica - imunosupresivi - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Madopar 100 mg/25 mg tablete Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

madopar 100 mg/25 mg tablete

roche d.o.o. - benserazid; levodopa - tableta - benserazid 25 mg / 1 tableta  levodopa100 mg / 1 tableta; levodopa 100 mg / 1 tableta - levodopa in zaviralec dekarboksilaze

Dormicum 1 mg/ml raztopina za injiciranje ali infundiranje Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

dormicum 1 mg/ml raztopina za injiciranje ali infundiranje

roche d.o.o. - midazolam - raztopina za injiciranje/infundiranje - midazolam 1 mg / 1 ml - midazolam

Dormicum 5 mg/ml raztopina za injiciranje ali infundiranje Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

dormicum 5 mg/ml raztopina za injiciranje ali infundiranje

roche d.o.o. - midazolam - raztopina za injiciranje/infundiranje - midazolam 5 mg / 1 ml - midazolam

Roaccutane 10 mg mehke kapsule Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

roaccutane 10 mg mehke kapsule

roche d.o.o. - izotretinoin - kapsula, mehka - izotretinoin 10 mg / 1 kapsula - izotretinoin

Roaccutane 20 mg mehke kapsule Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

roaccutane 20 mg mehke kapsule

roche d.o.o. - izotretinoin - kapsula, mehka - izotretinoin 20 mg / 1 kapsula - izotretinoin

Roferon-A 4,5 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

roferon-a 4,5 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi

roche d.o.o. - interferon alfa-2a, rekombinantni - raztopina za injiciranje - interferon alfa-2a, rekombinantni 4500000 i.e. / 0,5 ml - interferon alfa-2a

Roferon-A 6 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

roferon-a 6 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi

roche d.o.o. - interferon alfa-2a, rekombinantni - raztopina za injiciranje - interferon alfa-2a, rekombinantni 6000000 i.e. / 0,5 ml - interferon alfa-2a

Avastin Evropska unija - slovenščina - EMA (European Medicines Agency)

avastin

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - antineoplastična sredstva - bevacizumab v kombinaciji s kemoterapijo na osnovi fluoropirimidina je indiciran za zdravljenje odraslih bolnikov z metastatskim karcinomom debelega črevesa ali danke. bevacizumab je v kombinaciji z paclitaxel je določen za prvo linijo za zdravljenje odraslih bolnikov z metastatskim rakom dojke,. za dodatne informacije, kot na človeško epidermalna rast factor receptor 2 (her2) stanje. bevacizumab je v kombinaciji z capecitabine je določen za prvo linijo za zdravljenje odraslih bolnikov z metastatskim rakom dojke, pri katerih zdravljenje z drugimi kemoterapijo možnosti, vključno z taxanes ali anthracyclines se ne šteje za primerno. bolnike, ki so v obdobju 12 mesecev prejemali zdravljenje, ki vsebuje zdravljenje s taksanom in antraciklinom v dodatku, je treba izključiti iz zdravljenja z zdravilom avastin v kombinaciji s kapecitabinom. za nadaljnje informacije, kot da her2 status. bevacizumab, poleg platinum, ki temelji kemoterapijo, je označen za prvo linijo zdravljenja odraslih bolnikih z unresectable napredno, metastatskega ali ponavljajoče se non-small cell lung cancer razen pretežno skvamoznih celic histologija. bevacizumab je v kombinaciji z erlotinib, je označen za prvo linijo zdravljenja odraslih bolnikih z unresectable napredno, metastatskega ali ponavljajoče se non-skvamoznih non-small cell lung cancer z epidermalna rastni dejavnik receptorjev (egfr) aktiviranjem mutacije. bevacizumab je v kombinaciji z interferonom alfa-2a, ki je navedena za prvi vrstici zdravljenje odraslih bolnikov z napredno in/ali metastatskim karcinomom raka. bevacizumab je v kombinaciji z carboplatin in paclitaxel je označena na sprednji strani-line zdravljenje odraslih bolnikov z napredovalim (international federation of porodništva in ginekologije (figo) faze iii b, iii c in iv) epitelnih jajčnikov, fallopian tube, ali primarni trebušno raka. bevacizumab je v kombinaciji z carboplatin in gemcitabine, je indicirano za zdravljenje odraslih bolnikov s prvo ponovitev platinum-občutljive epitelnih jajčnikov, fallopian tube ali primarni trebušno raka, ki še niso prejeli pred terapijo z bevacizumab ali drugih vegf inhibitorji ali vegf receptor–ciljno agenti. bevacizumab je v kombinaciji z paclitaxel, topotecan, ali pegylated liposomal doxorubicin je indiciran za zdravljenje odraslih bolnikov s platino-odporne periodično epitelnih jajčnikov, fallopian tube, ali primarni trebušno raka, ki so prejeli več kot dve pred kemoterapijo regimens in ki ga še niso prejeli pred terapijo z bevacizumab ali drugih vegf inhibitorji ali vegf receptor–ciljno agenti. bevacizumab je v kombinaciji z paclitaxel in cisplatin, ali, alternativno, paclitaxel in topotecan pri bolnikih, ki ne morejo prejemati platinum terapija je primerna za zdravljenje odraslih bolnikov z vztrajno, periodično, ali metastatskim karcinom materničnega vratu.