Dengvaxia Evropska unija - islandščina - EMA (European Medicines Agency)

dengvaxia

sanofi pasteur - chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated) - fjölmörgum - bóluefni - dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4. 2, 4. 4 og 4. notkun dengvaxia ætti að vera í samræmi við opinbera tillögur.

Faslodex Evropska unija - islandščina - EMA (European Medicines Agency)

faslodex

astrazeneca ab - fulvestrant - brjóstakrabbamein - annarra meðferð, anti-estrógen - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. , Í leik - eða perimenopausal konur, samsetningu meðferð með palbociclib ætti að vera ásamt blóðkornunum á nýja-sjálandi (lhrh) örva.

Enjaymo Evropska unija - islandščina - EMA (European Medicines Agency)

enjaymo

sanofi b.v. - sutimlimab - hemolysis; anemia, hemolytic, autoimmune - Ónæmisbælandi lyf - enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (cad).

Capecitabine Teva Evropska unija - islandščina - EMA (European Medicines Agency)

capecitabine teva

teva pharma b.v. - capecítabín - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - Æxlishemjandi lyf - capecitabine teva er ætlað til viðbótarmeðferðar hjá sjúklingum eftir skurðaðgerð á iii. stigs stigi (dukes stig c) krabbamein í ristli. capecitabine mg er ætlað fyrir meðferð af sjúklingum krabbameini. capecitabine mg er ætlað fyrir fyrsta lína meðferð háþróaður krabbamein í maga ásamt platínu‑byggt meðferð. capecitabine mg í ásamt docetaxel er ætlað fyrir sjúklinga með staðnum háþróaður eða brjóstakrabbamein eftir bilun frumudrepandi lyfjameðferð. fyrri meðferð ætti að hafa innihaldið anthracyclin. capecitabine mg er einnig ætlað eitt og sér fyrir sjúklinga með staðnum háþróaður eða brjóstakrabbamein eftir bilun taxani og anthracycline inniheldur lyfjameðferð meðferð eða fyrir hvern frekar anthracycline meðferð er ekki ætlað.

Cerdelga Evropska unija - islandščina - EMA (European Medicines Agency)

cerdelga

sanofi b.v. - eliglustat - gauchersjúkdómur - Önnur meltingarvegi og efnaskipti vörur, - cerdelga er ætlað til lengri tíma meðferð fullorðinn sjúklinga með eins sjúkdómur tegund 1 (gd1), sem eru cyp2d6 léleg metabolisers (fyrirtíðaspennu), millistig metabolisers (skilaboð) eða mikla metabolisers (sjúkrabíl).

Jevtana Evropska unija - islandščina - EMA (European Medicines Agency)

jevtana

sanofi winthrop industrie - cabazitaxel - blöðruhálskirtli - Æxlishemjandi lyf - jevtana ásamt prednisone eða prednisólóni er ætlað fyrir sjúklinga með hormón-svarar sjúklingum krabbamein í blöðruhálskirtli áður meðhöndluð með docetaxel-inniheldur meðferð.

Nucala Evropska unija - islandščina - EMA (European Medicines Agency)

nucala

glaxosmithkline trading services - mepolizumab - astma - lyf til veikindi öndunarvegi sjúkdómum, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Retsevmo Evropska unija - islandščina - EMA (European Medicines Agency)

retsevmo

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - Æxlishemjandi lyf - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Lynparza Evropska unija - islandščina - 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.