Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration ltd. - ibandrónsýra - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð beinþynningar hjá konum eftir tíðahvörf við aukna hættu á beinbrotum. lækkun í hættu á hryggbrot hefur verið sýnt. verkun á lærlegg-háls beinbrot hefur ekki verið staðfest.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - daclatasvir díhýdróklóríð - lifrarbólga c, langvinn - veirueyðandi lyf til almennrar notkunar - daklinza er ætlað í samsettri meðferð með öðrum lyfjum til meðferðar við langvinna lifrarbólgu c veiru (hcv) sýkingu hjá fullorðnum (sjá kafla 4. 2, 4. 4 og 5. fyrir hcv arfgerð sérstakur starfsemi, sjáðu kafla 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - skert umbrot brómíð - lungnasjúkdómur, langvarandi hindrandi - lyf til veikindi öndunarvegi sjúkdómum, - tilkynnt sem viðhaldsberkjuvíkkandi meðferð til að létta einkenni hjá fullorðnum sjúklingum með langvinna lungnateppu (copd).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - Æxlishemjandi lyf - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris is indicated for the treatment of adult patients with relapsed or refractory cd30+ hodgkin lymphoma (hl):following asct, orfollowing at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option. systemic anaplastic large cell lymphomaadcetris in combination with cyclophosphamide, doxorubicin and prednisone (chp) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - valdar ónæmisbælandi lyf - sárum colitisentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka sárum niðurgang sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. crohn-diseaseentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka crohn-sjúkdóm sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merz pharmaceuticals gmbh - memantínhýdróklóríð - alzheimer sjúkdómur - Önnur lyf gegn vitglöpum - meðferð sjúklinga með miðlungsmikla til alvarlega alzheimerssjúkdóma.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

archie samiel s.r.o. - klópídógrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - blóðþurrðandi lyf - eða er ætlað í fullorðnir til að fyrirbyggja atherothrombotic atburðum í:sjúklingar sem þjáist af kransæðastíflu (frá nokkrum dögum fyrr en minna en 35 dögum), blóðþurrðar heilablóðfall (frá 7 daga þar til að minna en 6 mánuðum) eða komið útlæga slagæð sjúkdómur;sjúklingar sem þjáist af bráðu kransæðastíflu:ekki-l-hluti-hæð bráð kransæðastíflu (óstöðug hálsbólgu eða ekki q bylgju-kransæðastíflu), þar á meðal sjúklinga gangast undir stoðneti staðsetningar eftir stungið kransæðastíflu afskipti, ásamt asetýlsalisýlsýru (asa);l-hluti-hæð, bráð myndun stíflufleygs, ásamt asa í læknisfræðilega sjúklingum rétt fyrir segaleysandi meðferð.

Evrópusambandið - íslenska - 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.