Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi winthrop industrie - dronedarón - gáttatif - hjarta meðferð - multaq er ætlað til viðhalds sinus taktar eftir árangursríka hjartalínurit hjá fullorðnum klínískum stöðugum sjúklingum með paroxysmal eða viðvarandi gáttatif (af). vegna þess að öryggi, multaq ætti bara að vera mælt eftir aðra valkosti meðferð hefur verið talin.. multaq ætti ekki að gefa sjúklingum með vinstri op slagbils truflun eða að sjúklingar með núverandi eða fyrri þáttur af hjartabilun.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

correvio - vernakalant stutt og long-term - gáttatif - hjarta meðferð - hraðri viðskipti á undanförnum upphaf gáttum tif að sínustakti í fullorðnir:fyrir utan sjúklingum skurðaðgerð: gáttum tif .

Evrópusambandið - íslenska - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi 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). onbevzi 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 onbevzi in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, 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. onbevzi, 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio 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). 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. 1 of the smpc. aybintio, 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. aybintio, 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. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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. aybintio, 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

hcs bvba  - clopidogrel (as hydrochloride) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - blóðþurrðandi lyf - efri fyrirbyggja atherothrombotic eventsclopidogrel er ætlað:fullorðinn 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. fullorðinn sjúklingar sem þjáist af bráðu kransæðastíflu:ekki l hækkun bráð kransæðastíflu (óstöðug hálsbólgu eða ekki q-bylgja kransæðastíflu), þar á meðal sjúklinga gangast undir stoðneti staðsetningar eftir stungið kransæðastíflu afskipti, ásamt asetýlsalisýlsýru (asa). l hækkun, bráð myndun stíflufleygs, ásamt asa í læknisfræðilega sjúklingum rétt fyrir segaleysandi meðferð. fyrirbyggja atherothrombotic og bláæðum atburðum í gáttum fibrillationin fullorðinn sjúklinga með gáttum tif sem hafa minnsta kosti einn hættu þáttur í æðum viðburði, eru ekki við hæfi fyrir meðferð með c-k-mótlyf (vka) og sem hafa lágt blæðingar hættu, eða er ætlað ásamt asa til að fyrirbyggja atherothrombotic og bláæðum viðburði, þar á meðal heilablóðfall.  for further information please refer to section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

taw pharma (ireland) limited - klópídógrel hýdróklóríð - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - blóðþurrðandi lyf - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. , - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). ,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mallinckrodt pharmaceuticals ireland limited - mannafíbrógen manna, trombín manna - hemostasis, skurðaðgerð - antihemorrhagics - stuðningsmeðferð þar sem venjulegar skurðaðgerðir eru ekki nægjanlegar til að bæta blóðflæði. raplixa verður að nota í ásamt samþykkt gelatín svampur. raplixa er ætlað í fullorðnir yfir 18 ára aldri.

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).

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

stada arzneimittel ag - dronedaronum hýdróklóríð - filmuhúðuð tafla - 400 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gen.orph - miglustat - gauchersjúkdómur - Önnur meltingarvegi og efnaskipti vörur, - miglustat gen. orph er ætlað fyrir inntöku meðferð fullorðinn sjúklinga með vægt til í meðallagi tegund 1 eins og sjúkdómurinn. miglustat gen. orph kann að vera notað eina í meðferð sjúklinga sem ensím skipti meðferð er ekki við hæfi. miglustat gen. orph er ætlað fyrir meðferð framsækið taugakerfi í fullorðinn sjúklingum og börn sjúklinga með niemann-taka tegund c sjúkdómur.