Unión Europea - noruego - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infeksjoner - antivirale midler til systemisk bruk - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Unión Europea - noruego - EMA (European Medicines Agency)

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - sex hormoner og modulatorer av genital systemet, - oral contraceptive.

Unión Europea - noruego - EMA (European Medicines Agency)

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - sex hormoner og modulatorer av genital systemet, - oral prevensjon. the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4. 3 and 4.

Unión Europea - noruego - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karsinom, ikke-småcellet lunge - antineoplastiske midler - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Unión Europea - noruego - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastiske midler - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Unión Europea - noruego - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastiske midler - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Unión Europea - noruego - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - legemidler som brukes i diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. triple kombinasjon terapi) som et tillegg til diett og trening hos pasienter ikke kontrollert på deres maksimal tolerert dose av metformin og en sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Unión Europea - noruego - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirenz - hiv-infeksjoner - antivirale midler til systemisk bruk - stocrin er indisert i antiviral kombinationsbehandling av humane immunsvikt-virus-1 (hiv-1) -infiserte voksne, ungdommer og barn tre år og eldre. stocrin ikke har vært tilstrekkelig undersøkt hos pasienter med fremskreden hiv-sykdom, nemlig hos pasienter med cd4 teller < 50 celler/mm3, eller etter svikt av protease-inhibitor (pi)-inneholder regimer. selv om cross-motstand av efavirenz med pis har ikke blitt dokumentert, er det per i dag ikke nok data om effekten av påfølgende bruk av pi-basert kombinasjonsbehandling etter svikt av regimer som inneholder stocrin.

Unión Europea - noruego - EMA (European Medicines Agency)

abbvie ltd - dasabuvirnatrium - hepatitt c, kronisk - antivirale midler til systemisk bruk - exviera er angitt i kombinasjon med andre legemidler til behandling av kronisk hepatitt c (chc) hos voksne. for hepatitt c-virus (hcv) genotypen bestemt aktivitet.

Unión Europea - noruego - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nevirapin - hiv-infeksjoner - antivirale midler til systemisk bruk - tabletter og muntlig suspensionviramune er indisert i kombinasjon med andre antiretroviral legemidler til behandling av hiv-1-infiserte voksne, ungdom og barn i alle aldre. de fleste av erfaring med viramune er i kombinasjon med nucleoside revers-transkriptase-hemmere (nrtis). valget av en etterfølgende behandling etter viramune bør være basert på klinisk erfaring og motstand testing. 50 - og 100-mg langvarig-release tabletsviramune er indisert i kombinasjon med andre antiretroviral legemidler til behandling av hiv-1-smittet, ungdom og barn i tre år og over og i stand til å svelge tabletter. langvarig-release tabletter er ikke egnet for den 14-dagers innledende fase for pasienter som starter nevirapine. andre nevirapine formuleringer, for eksempel umiddelbar release tabletter eller mikstur bør brukes. de fleste av erfaring med viramune er i kombinasjon med nucleoside revers-transkriptase-hemmere (nrtis). valget av en etterfølgende behandling etter viramune bør være basert på klinisk erfaring og motstand testing. 400 mg langvarig-release tabletsviramune er indisert i kombinasjon med andre antiretroviral legemidler til behandling av hiv-1-infiserte voksne, ungdom og barn i tre år og over og i stand til å svelge tabletter. langvarig-release tabletter er ikke egnet for den 14-dagers innledende fase for pasienter som starter nevirapine. andre nevirapine formuleringer, for eksempel umiddelbar release tabletter eller mikstur bør brukes. de fleste av erfaring med viramune er i kombinasjon med nucleoside revers-transkriptase-hemmere (nrtis). valget av en etterfølgende behandling etter viramune bør være basert på klinisk erfaring og motstand testing.