Europska Unija - islandski - EMA (European Medicines Agency)

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

Europska Unija - islandski - 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.

Europska Unija - islandski - EMA (European Medicines Agency)

merck sharp and dohme b.v - sjúklingum - lifrarbólga c, langvinn - antivirals for systemic use, antivirals for treatment of hcv infections - rebetol er ætlað í samsettri meðferð með öðrum lyfjum til meðferðar við langvarandi lifrarbólgu c (chc) hjá fullorðnum. rebetol er ætlað ásamt öðrum lyf til meðferð langvarandi lifrarbólgu c (chc) fyrir börn sjúklingar (börn 3 ára og eldri og unglingar) ekki áður meðferð og án lifur lifrarbilun.

Europska Unija - islandski - EMA (European Medicines Agency)

amryt ag - betulae cortex - wounds and injuries; wound healing - undirbúningur til meðferðar á sár og sár - meðferð á þykktum í þykktum hjá fullorðnum. sjá kafla 4. 4 og 5. 1 í upplýsingum um vörur með tilliti til tegundar sárs sem rannsakað er.

Europska Unija - islandski - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, systemic - Ónæmisbælandi lyf - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Europska Unija - islandski - EMA (European Medicines Agency)

novartis europharm limited - telbivudin - lifrarbólga b, langvarandi - nucleoside and nucleotide reverse transcriptase inhibitors - sebivo er ætlað fyrir meðferð langvarandi lifrarbólgu b í fullorðinn sjúklinga með bætt lifrarsjúkdóm og vísbendingar um friðhelgi eftirmyndun, stöðugt hækkað blóðvatn alanínamínótransferasa (alt) stigum og vefja vísbendingar um virka bólgu og/eða bandvefsmyndun. upphaf sebivo meðferð ætti bara að vera talin þegar nota aðra veirum umboðsmaður með hærri erfðafræðilega hindrun að mótstöðu er ekki í boði eða viðeigandi.

Europska Unija - islandski - EMA (European Medicines Agency)

roche registration gmbh - metoxý annara hættu efst-epóetín beta - anemia; kidney failure, chronic - sýklalyf - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Europska Unija - islandski - EMA (European Medicines Agency)

sandoz gmbh - natalízúmab - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ónæmisbælandi lyf - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 og 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Europska Unija - islandski - EMA (European Medicines Agency)

viiv healthcare bv - áhrif, zídóvúdíns - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - combivir is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection.

Europska Unija - islandski - EMA (European Medicines Agency)

teva pharma b.v.  - áhrif, zídóvúdíns - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - lamivúdín / zídóvúdín teva er ætlað í samsettri andretróveirulyfjameðferð til meðferðar við hiv-sýkingum (human immunodeficiency virus).