Evrópusambandið - íslenska - EMA (European Medicines Agency)

laboratorios hipra s.a. - inactivated bordetella bronchiseptica, strain 833cer, recombinant type-d pasteurella-multocida toxin - Ónæmisfræðilegar upplýsingar - svín (gilts og sows) - fyrir óbeinum vernd grísi með brodd eftir að virka bólusetningar af sáir og gyltur til að draga úr klínískum merki og sár framsækið og ekki framsækið rýrnunar nefi, eins og til að draga úr þyngd tap í tengslum við bordetella-bronchiseptica og pasteurella-multocida sýkingum á fitandi tímabil. Áskorun rannsóknir hafa sýnt fram á að aðgerðalaus friðhelgi stendur til grísi eru sex vikna en í klínískum sviði rannsóknum, áhrifin á bólusetningu (lækkun í nefi sár skora og þyngd tap) eru fram þar til slátrunar.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi pasteur europe - inflúensu veira (óvirkt, hættu) eftir stofnar:a/kaliforníu/7/2009 (h1n1)pdm09 - eins og álag (a/kaliforníu/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) - eins og álag (a/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - eins og álag (b/brisbane/60/2008, wild tegund) - influenza, human; immunization - bóluefni - fyrirbyggjandi meðferð inflúensu hjá einstaklingum 60 ára og eldri, sérstaklega hjá þeim sem hafa aukna hættu á fylgikvilla. notkun ekki ætti að vera byggt á opinberum tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

hra pharma rare diseases - ketókónazól - cushing heilkenni - sveppalyf fyrir almenn nota - ketókónazól hra er ætlað til meðferðar við cushing heilkenni hjá fullorðnum og unglingum eldri en 12 ára.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparaginasi - forvarnarfrumuæxli-eitilfrumuhvítblæði - Æxlishemjandi lyf - spectrila er ætlað sem hluti af æxlishemjandi samsettri meðferð til meðhöndlunar á bráðum eitilfrumuhvítblæði (all) hjá börnum frá fæðingu til 18 ára og fullorðna.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227) / a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238) / b/phuket/3073/2013-like strain (b/phuket/3073/2013, bvr-1b) / influenza virus b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26) - inflúensu, manna - bóluefni - fyrirbyggjandi inflúensu í aldraða (65 ára og eldri). fluad fjór ætti að vera notuð í samræmi við opinbera tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatíð - beinþynning - kalsíumsterastasis - qutavina is indicated in adults. meðferð við beinþynningu hjá konum eftir tíðahvörf og karlar við aukna hættu á beinbrotum. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. meðferð beinbrot tengslum við viðvarandi almenn sykurstera meðferð í konur og menn á jókst hættan fyrir beinbrot.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

diurnal europe b.v. - hýdrókortisón - adrenal hyperplasia, congenital - barksterar til almennrar notkunar - treatment of congenital adrenal hyperplasia (cah) in adolescents aged 12 years and over and adults.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomectin, esafoxolaner, praziquantel - eprinomectin, combinations, , avermectins, antiparasitic products, insecticides and repellents - kettir - for cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. dýralæknis lyf er eingöngu ætlað þegar allt þrjá hópa eru miða á sama tíma.

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.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

viatris aps - b/phuket/3073/2013-líkur stofn (b/phuket/3073/2013, villigerð); a/victoria/2570/2019 (h1n1)pdm09 - líkur stofn (a/victoria/2570/2019, ivr-215); a/darwin/9/2021 (h3n2)- líkur stofn (a/darwin/9/2021, san-010); b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26) - stungulyf, dreifa í áfylltri sprautu - 15/15/15/15 míkróg/skammt