Unión Europea - islandés - EMA (European Medicines Agency)

astrazeneca ab  - sjúklingar stutt og long-term, saxagliptin stutt og long-term - sykursýki, tegund 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze er ætlað sem viðbót til að fæði og æfa til að bæta blóðsykursstjórnun í fullorðinn sjúklingar 18 ára og eldri með tegund-2 sykursýki ekki nægilega stjórn á eigin hámarks þolað skammt af kvarta einn eða þá þegar í meðferð með blöndu af saxagliptin og sjúklingar eins og að aðskilja töflur. komboglyze er einnig ætlað ásamt insúlín (ég. þrefaldur samsetning meðferð) sem viðbót til að fæði og æfa til að bæta blóðsykursstjórnun í fullorðinn sjúklingar 18 ára og eldri með tegund-2 sykursýki þegar insúlín og kvarta einn veita ekki fullnægjandi blóðsykursstjórnun.

Unión Europea - islandés - EMA (European Medicines Agency)

astrazeneca ab - roflumilast - lungnasjúkdómur, langvarandi hindrandi - lyf til veikindi öndunarvegi sjúkdómum, - libertek er ætlað fyrir viðhald meðferð alvarlega langvinn veikindi í lungum (llt) (fev1 post-berkjuvíkkandi minna en 50% spáð) í tengslum við langvarandi bronkítis í fullorðinn sjúklinga með sögu um tíð tilvikum eins og bæta-á að berkjuvíkkandi meðferð.

Unión Europea - islandés - EMA (European Medicines Agency)

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.

Unión Europea - islandés - EMA (European Medicines Agency)

swedish orphan biovitrum ab - kollagenasa clostridium histolyticum - dupuytren samningur - Önnur lyf við sjúkdómum í stoðkerfi - , the treatment of dupuytren’s contracture in adult patients with a palpable cord. meðferð fullorðnir menn með sjúkdómur með teljandi sýklum og sveigju bæklun að minnsta kosti 30 gráður í upphafi meðferð.

Unión Europea - islandés - EMA (European Medicines Agency)

astrazeneca ab - palivizumab - sýkingar af völdum sýklalyfja - Ónæmiskerfið sera og mótefni, - palivizumabs er ætlað til að fyrirbyggja alvarleg neðri-öndunarfærum-svæði sjúkdómur þurfa innlögn á sjúkrahús af völdum öndunarfærum syncytial veira (rannsÓkninni) í börn í mikilli hættu fyrir rannsÓkninni sjúkdómur:börn fæddust á 35 vikur af meðgöngu eða minna og minna en sex mánaða aldur á upphaf rannsÓkninni tímabili, börn minna en tvær ára aldri og þurfa meðferð fyrir u dysplasia innan síðustu sex mánuði, börn minna en tvær ára aldri og með haemodynamically verulega meðfæddan hjartasjúkdóm.

Unión Europea - islandés - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - Æxlishemjandi lyf - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Unión Europea - islandés - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - krabbamein, lungnakrabbamein - Önnur antineoplastic lyf, prótín nt-hemlar - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Unión Europea - islandés - EMA (European Medicines Agency)

astrazeneca ab - ticagrelor - peripheral vascular diseases; acute coronary syndrome - blóðþurrðandi lyf - possia, sam-gefið með asetýlsalisýlsýru (asa), er ætlað til að fyrirbyggja atherothrombotic atburðum í fullorðinn sjúklinga með bráð kransæðastíflu heilkennum (óstöðug hjartslætti, non-l-hæð kransæðastíflu [nstemi] eða l-hæð kransæðastíflu [st-hækkun]); þar á meðal sjúklinga tókst læknisfræðilega, og þeir sem er stjórnað með stungið kransæðastíflu afskipti (náist á ný) eða hjarta slagæð með því-að fara að græða (hjÁveituaÐgerÐ).

Unión Europea - islandés - EMA (European Medicines Agency)

immedica pharma ab - glýseról fenýlbútýrat - Þvagfærasýkingar, innfæddir - Önnur meltingarvegi og efnaskipti vörur, - ravicti er ætlað til að nota eins og venjulega meðferð fyrir langvarandi stjórnun sjúklinga með súrefnismettun hringrás vandamál (ucds) þar á meðal galla á karbamóýl fosfórinn-þétti-ég (suv), ornithine carbamoyltransferase (otc), argininosuccinate lígasa (rass), argininosuccinate lýasa (ys), arginase ég (rÖk) og ornithine translocase skort hyperornithinaemia-hyperammonaemia homocitrullinuria heilkenni (hhh) sem getur ekki verið stjórnað af mataræði prótín takmörkun og/eða amínósýruna viðbót einn. ravicti verður að nota með mataræði prótín takmörkun og í sumum tilfellum, fæðubótarefni (e. , nauðsynleg amínósýrur, arginín, sítrólín, próteinlaus viðbót við kaloría).

Unión Europea - islandés - EMA (European Medicines Agency)

meda ab - zaleplon - svefntruflun og viðhald - psycholeptics - sonata er ætlað til meðferðar hjá sjúklingum með svefnleysi sem eiga erfitt með að sofna. Það er ætlað aðeins þegar röskun er alvarlegt, slökkva eða láta einstaka til mikillar neyð.