Vegzelma Европейский союз - исландский - EMA (European Medicines Agency)

vegzelma

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.

Pixuvri Европейский союз - исландский - EMA (European Medicines Agency)

pixuvri

les laboratoires servier - pixantrón dimaleat - eitilæxli, non-hodgkin - Æxlishemjandi lyf - pixuvri er ætlað sem einlyfjameðferð til meðferðar hjá fullorðnum sjúklingum með margfalda endurtekna eða eldföstum árásargjarnan hodgkin b-eitilæxli (nhl). ekki hefur verið sýnt fram á ávinning af meðferð með pixantróni hjá sjúklingum þegar þau eru notuð sem fimmta línu eða meiri krabbameinslyfjameðferð hjá sjúklingum sem eru eldföstir við síðasta meðferð.

Cometriq Европейский союз - исландский - EMA (European Medicines Agency)

cometriq

ipsen pharma - cabozantinib - skjaldkirtilsæxli - Æxlishemjandi lyf - meðferð hjá fullorðnum sjúklingum með framsækið, óleysanlegt, staðbundið langt gengið eða meinvörpað skjaldkirtilskrabbamein.

Sycrest Европейский союз - исландский - EMA (European Medicines Agency)

sycrest

n.v. organon - asenapine (as maleate)  - geðhvarfasýki - psycholeptics - sycrest er ætlað til meðferðar á miðlungsmiklum til alvarlegum manískum þáttum sem tengjast geðhvarfasýki í fullorðnum.

Doptelet Европейский союз - исландский - EMA (European Medicines Agency)

doptelet

swedish orphan biovitrum ab (publ) - avatrombopag maleate - blóðflagnafæð - antihemorrhagics - doptelet er ætlað fyrir meðferð alvarlega blóðflagnafæð í fullorðinn sjúklinga með langvarandi lifrarsjúkdóm sem eru áætlað er að gangast undir innrásar aðferð. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. barkstera, immúnóglóbúlín).