Onsior Evrópusambandið - íslenska - EMA (European Medicines Agency)

onsior

elanco gmbh - robenacoxib - anti-inflammatory and anti-rheumatic products, non-steroids, coxibs - dogs; cats - kettir (töflur):fyrir treatmentrelief af sársauka og bólgu í tengslum við bráð andor langvarandi stoðkerfi kvilla. fyrir lækkun í meðallagi sársauka og bólgu í tengslum við aðgerð orthopaedic. hundar (töflur):fyrir ttreatment af sársauka og bólgu í tengslum við langvarandi university of. fyrir meðferð af sársauka og bólgu í tengslum með mjúkum vefjum skurðaðgerð. kettir og hundar (lausn):fyrir ttreatment af sársauka og bólgu í tengslum við orthopaedic eða mjúkt vefjum skurðaðgerð.

Zavicefta Evrópusambandið - íslenska - EMA (European Medicines Agency)

zavicefta

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - sýklalyf fyrir almenn nota, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Lynparza Evrópusambandið - íslenska - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - Æxli í eggjastokkum - Æxlishemjandi lyf - blöðrur á cancerlynparza er ætlað eitt og sér fyrir:viðhald meðferð fullorðinn sjúklinga með langt (figo stigum iii og iv) brca1/2-stökkbreytt (germline og/eða líkamsvöxt) hágæða þekju blöðrur, eggjaleiðara eða aðal kviðarholi krabbamein sem eru í svar (heill eða hluta) eftir að ljúka fyrsta lína platínu-byggt lyfjameðferð. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 og 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. sjúklingar að hefur áður verið meðhöndluð með anthracycline og taxane í (neo)viðbótar eða sjúklingum setja nema sjúklinga sem voru ekki henta til þessara meðferða (sjá kafla 5. sjúklingar með hormón viðtaka (hr)-jákvæð brjóstakrabbamein ætti líka að hafa gengið á eða eftir áður en annarra meðferð, eða að vera talin óhæf til annarra meðferð. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Koselugo Evrópusambandið - íslenska - EMA (European Medicines Agency)

koselugo

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - Æxlishemjandi lyf - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Nulojix Evrópusambandið - íslenska - EMA (European Medicines Agency)

nulojix

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.