Den europeiske union - norsk - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabin - hiv-infeksjoner - antivirale midler til systemisk bruk - emtriva er indisert for behandling av hiv-1-infiserte voksne og barn i kombinasjon med andre antiretrovirale midler. denne indikatoren er basert på studier i behandling-naive pasienter og behandling-erfarne pasienter med stabil virologisk kontroll. det er ingen erfaring med bruk av emtriva hos pasienter som svikter sin nåværende regime eller som har unnlatt flere regimer. når du skal på en ny diett for pasienter som har mislyktes i en antiretroviral diett, forsiktig det bør vurderes å mønstre av mutasjoner assosiert med ulike legemidler og behandling historie av den enkelte pasient. der det er tilgjengelig, motstand testing kan være aktuelle.

Den europeiske union - norsk - EMA (European Medicines Agency)

dr. friedrich eberth arzneimittel gmbh - lasofoxifene tartrate - osteoporose, postmenopausale - sex hormoner og modulatorer av genital systemet, - fablyn er indisert for behandling av osteoporose hos postmenopausale kvinner med økt risiko for brudd. en signifikant reduksjon i forekomsten av vertebrale og ikke-vertebrale frakturer, men ikke hoftefrakturer, har blitt påvist (se avsnitt 5. når du skal bestemme valg av fablyn eller andre behandlingsformer, inkludert oestrogens, for postmenopausale kvinner, og det bør vurderes å menopausal symptomer, effekter på livmor og bryst vev, og kardiovaskulær risiko og fordeler (se punkt 5..

Den europeiske union - norsk - EMA (European Medicines Agency)

vanda pharmaceuticals netherlands b.v. - tasimelteon - søvnforstyrrelser, sirkadisk rytme - psykoleptiske - hetlioz er indisert for behandling av ikke-24-timers sove-våkne lidelse (non-24) i helt blind voksne.

Den europeiske union - norsk - EMA (European Medicines Agency)

incline therapeutics europe ltd - fentanylhydroklorid - smerte, postoperativ - analgetika - ionsys er indisert for behandling av akutte moderat til alvorlig postoperativ smerte hos voksne pasienter.

Den europeiske union - norsk - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - lopinavir, ritonavir - hiv-infeksjoner - antivirals for systemic use, protease inhibitors - kaletra er angitt i kombinasjon med andre antiretrovirale legemidler til behandling av hiv-1-infiserte voksne, ungdommer og barn i alderen 14 og eldre. valg av kaletra til å behandle protease inhibitor opplevd hiv-1 infiserte pasienter bør være basert på individuelle viral motstand testing og behandling historie av pasienter.

Den europeiske union - norsk - 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 - antineoplastiske midler - 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. pasienter med egfr eller alk positive svulsten mutasjoner bør også ha mottatt målrettet terapi før du mottar 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.

Den europeiske union - norsk - EMA (European Medicines Agency)

aziende chimiche riunite angelini francesco s.p.a. - lurasidone - schizofreni - psykoleptiske - behandling av schizofreni hos voksne over 18 år og over.

Den europeiske union - norsk - EMA (European Medicines Agency)

ucb pharma s.a.   - rotigotin - restless legs syndrome; parkinson disease - anti-parkinson medisiner - leganto er indisert for symptomatisk behandling av moderat til alvorlig idiopatisk restless-legs syndrom hos voksne. leganto er angitt for behandling av tegn og symptomer på et tidlig stadium idiopatisk parkinsons sykdom, som monoterapi (jeg. uten levodopa) eller i kombinasjon med levodopa, i. i løpet av sykdommen, gjennom til slutten stadier når effekten av levodopa avtar eller blir ustabil og fluktuasjoner i terapeutisk effekt oppstår (slutten av dose eller "on-off" - fluktuasjoner).

Den europeiske union - norsk - EMA (European Medicines Agency)

orion corporation - levodopa, carbidopa, entacapone - parkinsonsykdom - nervesystemet - carbidopa/levodopa/entacapone orion er indisert for behandling av voksne pasienter med parkinsons sykdom og slutten av dose motor svingninger ikke stabilisert på levodopa / dopa-dekarboksylasehemmer (ddc)-hemmer behandling.

Den europeiske union - norsk - EMA (European Medicines Agency)

upjohn eesv - pregabalin - epilepsy; anxiety disorders; neuralgia - antiepileptics, , andre antiepileptics - nevropatisk painlyrica er angitt for behandling av perifer og sentral nevropatisk smerte hos voksne. epilepsylyrica er indisert som tilleggsbehandling hos voksne med partielle anfall med eller uten sekundær generalisering. generell angst disorderlyrica er angitt for behandling av generalisert angstlidelse (gad) i voksne.