Evrópusambandið - íslenska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystic fibrosis - Önnur öndunarfæri - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glenmark pharmaceuticals s.r.o.  - olanzapin - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine er ætlað fyrir meðferð geðklofa. olanzapin er virkt í að viðhalda klínískum endurbætur á áframhaldandi meðferð í sjúklingum sem hafa sýnt upphaflega meðferð svar. olanzapin er ætlað fyrir meðferð í meðallagi til alvarlega oflæti þættinum. Í sjúklingar sem oflæti þáttur hefur brugðist að olanzapin meðferð, olanzapin er ætlað til að fyrirbyggja endurkomu í sjúklinga með geðhvarfasýki.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ceva santé animale - influenza a virus/human strain: a/jena/vi5258/2009 (h1n1)pdm09, inactivated - Ónæmislyf, óvirkur veiru bóluefni fyrir svín, svín inflúensu veira - svín - virkt ónæmisaðgerðir svín frá 8 vikna aldri gegn h1n1 svín inflúensuveiru gegn heimsfaraldri til að draga úr veiruveiru og úthreinsun veiru. the vaccine can be used during pregnancy up to three weeks before expected farrowing and during lactation lactation.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - glycogen geymsluskammt tegund ii - Önnur meltingarvegi og efnaskipti vörur, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bavarian nordic a/s - vibrio cholerae, álag cvd 103-hgr, lifandi - cholera - bóluefni - vaxchora is indicated for active immunisation against disease caused by vibrio cholerae serogroup o1 in adults and children aged 2 years and older. Þetta bóluefni ætti að vera notuð í samræmi við opinbera tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - Æxlishemjandi lyf - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. sjúklingar með egfr eða t jákvæð æxli stökkbreytingar ætti líka að hafa fengið miða meðferð áður en þú færð keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck europe b.v. - avelumab - neuroendocrine tumors - Önnur antineoplastic lyf, hvolfi mótefni - bavencio er ætlað sem einlyfjameðferð til meðferðar hjá fullorðnum sjúklingum með merkel frumukrabbamein með meinvörpum (mcc). bavencio ásamt axitinib er ætlað fyrir fyrsta lína meðferð fullorðinn sjúklinga með langt skert klefi krabbamein (rcc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - bóluefni - ambirix er ætlað til notkunar hjá ónæmum einstaklingum frá einu ári til og þar á meðal 15 ára til verndar gegn lifrarbólgu-a og lifrarbólgu-b sýkingu. vörn gegn lifrarbólgu-b sýkingum getur ekki verið fengin fyrr en eftir seinni skammt. Því:ambirix skal aðeins notaður þegar það er tiltölulega lágar hættu lifrarbólgu-b sýkingu á bólusetningu auðvitað, það er mælt með að ambirix skal gefa í stillingar þar hinum tveimur-skammt bólusetningu auðvitað getur verið viss um.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharmaceuticals international ag - icatibant - ofsabjúgur, arfgengur - hjarta meðferð - firazyr er ætlað til meðferðar við bráðri árás arfgengs ofsabjúgs (hae) hjá fullorðnum (með skort á c1-esterasa-hemlum).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi b.v. - alglucosidasa alfa - glycogen geymsluskammt tegund ii - Önnur meltingarvegi og efnaskipti vörur, - myozyme er ætlað til langtíma ensímuppbótarmeðferðar (ert) hjá sjúklingum með staðfestan greiningu á pompe sjúkdómum (sýru-α-glúkósíðasa skortur). Í sjúklinga með seint-upphaf pompe sjúkdómur sönnun á virkni er takmörkuð.