Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - skammtar, notkunar í augu. maleat - glaucoma, open-angle; ocular hypertension - augnlækningar - minnkuð augnþrýstingur (iop) hjá fullorðnum sjúklingum með gláku í augnlokum eða augnháþrýstingi, sem einlyfjameðferð veldur ófullnægjandi blóðsykursfalli.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entecavir einhýdrat - lifrarbólga b - veirueyðandi lyf til almennrar notkunar - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. 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. entecavir mylan er einnig ætlað til meðferð langvarandi hbv sýkingu í núkleósíð barnaleg börn sjúklingar frá 2 til.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinux natríum - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - blóðþurrðandi lyf - 5 mg / 0. 3 ml og 2. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. fyrirbyggja vte í fullorðnir gangast undir kviðarholi sem eru dæmdir til að vera í mikilli hættu á segarek, eins og gangast undir kvið krabbamein skurðaðgerð. fyrirbyggja vte í fullorðinn læknis sjúklingum sem eru dæmdir til að vera í mikilli hættu fyrir vte og hver eru immobilised vegna þess að bráð veikindi eins og hjartabilun og / eða bráð sjúkdóma í öndunarfærum, og / eða bráð smitandi eða æsandi sjúkdómur. meðferð fullorðnir með bráð einkennum skyndileg yfirborðskennd-æð blóðtappa á fótleggjum án samhliða djúpt-æð blóðtappa. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. hjartaáfall (st-hækkun) í fullorðinn sjúklingum sem er stjórnað með segaleysandi eða sem upphaflega eru að fá engin önnur mynd af opna fyrir blóðflæðið meðferð. 5 mg / 0. 4-ml, 7. 5 mg / 0. 6-ml og 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - eptifibatíð - angina, unstable; myocardial infarction - blóðþurrðandi lyf - integrilin er ætlað til notkunar með asetýlsalicýlsýru og óþrýstinni heparíni. integrilin er ætlað til að fyrirbyggja snemma kransæðastíflu í sjúklingar að kynna með óstöðug hálsbólgu eða ekki q-bylgja kransæðastíflu með síðasta þátt brjóstverk koma innan 24 tíma og með hjartalÍnuriti og / eða hækkað hjarta ensím. sjúklingar líklega að njóta góðs af integrilin meðferð eru þeir á mikil hætta á að fá kransæðastíflu innan fyrsta 3-4 daga eftir upphaf bráð hjartslætti einkenni þar á meðal til dæmis þá sem eru líkleg til að fara snemma farið í kransæðavíkkun (kransÆÐavÍkkun).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Evrópusambandið - íslenska - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - Ónæmisbælandi lyf - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma 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). vegzelma 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 vegzelma in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, 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. vegzelma, 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evrópusambandið - íslenska - 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.