Evropska unija - norveščina - EMA (European Medicines Agency)

baxter holding b.v. - doxorubicin hydroklorid - sarcoma, kaposi; multiple myeloma; ovarian neoplasms; breast neoplasms - antineoplastiske midler - caelyx pegylated liposomal er angitt:som monoterapi til pasienter med metastatisk brystkreft, hvor det er en økt kardial risiko;for behandling av avansert eggstokkreft hos kvinner som har mislyktes i et første-linje platinum-basert kjemoterapi diett, i kombinasjon med bortezomib for behandling av progressive myelomatose hos pasienter som har fått minst ett før behandling, og som har gjennomgått eller er uegnet for bein marg transplantasjon, for behandling av aids-relatert kaposis sarkom (ks) hos pasienter med lave cd4 teller (.

Evropska unija - norveščina - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - bryst neoplasms - antineoplastiske midler - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Evropska unija - norveščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Evropska unija - norveščina - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicin hydroklorid - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastiske midler - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Evropska unija - norveščina - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastiske midler - hormon-reseptor-positiv avansert brystkreft cancerafinitor er angitt for behandling av hormon-reseptor-positiv, her2/neu-negative avansert brystkreft, i kombinasjon med exemestane, i post-menopausal kvinner uten symptomatisk visceral sykdom etter tilbakefall eller progresjon etter en non-steroid aromatasehemmer. nevroendokrine svulster i bukspyttkjertelen originafinitor er angitt for behandling av inoperabel eller metastatisk, godt eller middels differensiert nevroendokrine svulster i bukspyttkjertelen opprinnelse i voksne med progressiv sykdom. nevroendokrine svulster i fordøyelsessystemet eller lunge originafinitor er angitt for behandling av inoperabel eller metastatisk, godt differensiert (klasse 1 eller klasse 2) ikke-funksjonell nevroendokrine svulster i fordøyelsessystemet eller lunge opprinnelse i voksne med progressiv sykdom. nyre-celle carcinomaafinitor er indisert for behandling av pasienter med avansert nyre-cell carcinoma, hvis sykdommen har kommet på eller etter behandling med vegf-rettet behandling.

Evropska unija - norveščina - EMA (European Medicines Agency)

roche registration gmbh - cobimetinibhemifumarat - melanom - antineoplastiske midler - cotellic er indisert for bruk i kombinasjon med vemurafenib til behandling av voksne pasienter med uoppløselig eller metastatisk melanom med en braf v600 mutasjon.

Evropska unija - norveščina - 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.

Evropska unija - norveščina - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Evropska unija - norveščina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - guanfacin hydroklorid - attention deficit disorder med hyperaktivitet - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv må brukes som en del av en omfattende adhd behandling program, vanligvis inkludert psykologiske, pedagogiske og sosiale tiltak.

Evropska unija - norveščina - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - polycystic kidney, autosomal dominant - diuretika, - jinarc er angitt til langsom progresjonen av cyste utvikling og nyresvikt på autosomal dominant polycystic nyresykdom (adpkd) hos voksne med parallelt trinn 1 til 3 ved starten av behandling med bevis for raskt utvikle sykdom.