Island - islandsk - LYFJASTOFNUN (Icelandic Medicines Agency)

neutec inhaler ireland limited - salmeterolum xínafóat; fluticasonum própíónat - innöndunarduft, afmældir skammtar - 50 míkróg/500 míkróg/skammt

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - tópótecan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - Æxlishemjandi lyf - hycamtin hylki eru ætlaðar sem einlyfjameðferð til meðferðar hjá fullorðnum sjúklingum með endurkomið lungnakrabbamein í litlum frumum (sclc), sem ekki er talin endurmeðferð með fyrsta línunni.. tópótecan er ætlað fyrir sjúklinga með sjúklingum krabbamein eggjastokkum eftir bilun í fyrsta lína eða næstu meðferð. hycamtin hylki eru ætlaðar sem einlyfjameðferð til meðferðar hjá fullorðnum sjúklingum með endurkomið lungnakrabbamein í litlum frumum (sclc), sem ekki er talin endurmeðferð með fyrsta línunni..

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - Æxlishemjandi lyf - 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 eitt og sér er ætlað fyrir meðferð fullorðinn sjúklinga með staðnum háþróaður eða sjúklingum nsclc eftir áður en lyfjameðferð. 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 eitt og sér er ætlað fyrir meðferð fullorðinn sjúklinga með staðnum háþróaður eða sjúklingum nsclc eftir áður en lyfjameðferð. 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.

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - eitilfrumukrabbamein, mantle-cell - Æxlishemjandi lyf - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - entecavir - lifrarbólga b, langvarandi - veirueyðandi lyf til almennrar notkunar - baraclude er ætlað fyrir meðferð langvarandi lifrarbólgu b veira (hbv) sýkingu í fullorðnir með:bætt lifrarsjúkdóm og merki um virka veiru eftirmyndun, stöðugt hækkað blóðvatn alanínamínótransferasa (alt) stigum og vefja vísbendingar um virka bólgu og/eða bandvefsmyndun;alvarleg lifrarsjúkdóm. fyrir bæði bætt og alvarleg lifrarsjúkdóm, þetta vísbending er byggt á rannsókn gögn í núkleósíð barnaleg sjúklinga með hbeag jákvæð og hbeag neikvæð hbv sýkingu. með tilliti til sjúklinga með lifrarbólgu b sem eru með lamivúdín.

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

mabxience research sl - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Æxlishemjandi lyf - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with alymsys in combination with capecitabine. alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

stada arzneimittel ag - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Æxlishemjandi lyf - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. sjá nánar í kafla 5 til að fá nánari upplýsingar varðandi húðþéttni vaxtarþáttar viðtaka 2 (her2). oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with oyavas in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

ceva santé animale - erfðabreytt skal læknir hafa upplýsingar-eitur-2e antigen - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - svín - virkur ónæmisaðgerð grísla frá fjórum dögum, til að draga úr dauðsföllum og klínískum einkennum bjúgsjúkdóms af völdum shiga toxíns 2e framleitt með escherichia coli (stec). upphaf ónæmis: 21 dagar eftir bólusetningu. lengd ónæmis: 105 dögum eftir bólusetningu.

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

techdow pharma netherlands b.v.  - enoxaparínnatríum - bláæðasegarek - blóðþurrðandi lyf - inhixa er ætlað fyrir fullorðna fyrir:fyrirbyggja segareki, sérstaklega í gangast undir orthopaedic, hershöfðingi eða forvarnir skurðaðgerð. fyrirbyggja bláæðasegareki í sjúklingum rúmfastur vegna þess að bráð sjúkdóma þar á meðal bráð hjartabilun, bráðar bilun, alvarlega sýkingar, eins og versnað gigt veldur sjúkdómum hreyfingarleysi sjúklings (á við um styrkleika 40 mg/0. 4 ml). meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu), flókið eða óbrotinn með lungna-blóðtappa. meðferð óstöðug hjartslætti og ekki q bylgja kransæðastíflu, ásamt asetýlsalisýlsýru (asa). meðferð bráð l hækkun kransæðastíflu (st-hækkun) þar á meðal sjúklinga sem verður að meðhöndla eða íhaldssamur sem mun síðar gangast undir stungið kransæðavíkkun (á við um styrkleika 60 mg/0. 6 ml, 80 mg/0. 8 ml, og 100 mg/1 ml). blóðtappa að koma í veg í extracorporeal umferð á blóðskiljun.

Den Europæiske Union - islandsk - EMA (European Medicines Agency)

pharmathen s.a. - enoxaparínnatríum - bláæðasegarek - blóðþurrðandi lyf - thorinane er ætlað fyrir fullorðna fyrir: - fyrirbyggja segareki, sérstaklega í gangast undir orthopaedic, hershöfðingi eða forvarnir skurðaðgerð. - fyrirbyggja bláæðasegareki í sjúklingum rúmfastur vegna þess að bráð sjúkdóma þar á meðal bráð hjartabilun, bráðar bilun, alvarlega sýkingar, eins og versnað gigt veldur sjúkdómum hreyfingarleysi sjúklings (á við um styrkleika 40 mg/0. 4 ml). - meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu), flókið eða óbrotinn með lungna-blóðtappa. - meðferð óstöðug hjartslætti og ekki q bylgja kransæðastíflu, ásamt asetýlsalisýlsýru (asa). - meðferð bráð l hækkun kransæðastíflu (st-hækkun) þar á meðal sjúklinga sem verður að meðhöndla eða íhaldssamur sem mun síðar gangast undir stungið kransæðavíkkun (á við um styrkleika 60 mg/0. 6 ml, 80 mg/0. 8 ml, og 100 mg/1 ml). - blóðtappa að koma í veg í extracorporeal umferð á blóðskiljun. fyrirbyggja og meðferð af ýmsum truflunum sem tengjast blóðtappa í fullorðnir.