Euroopan unioni - norja - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiske midler - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. for ytterligere informasjon om human epidermal growth factor receptor 2 (her2) status, se avsnitt 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. for ytterligere informasjon om her2-status, se avsnitt 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Euroopan unioni - norja - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - antianemiske preparater - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Euroopan unioni - norja - 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 (.

Euroopan unioni - norja - 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.

Euroopan unioni - norja - 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).

Euroopan unioni - norja - EMA (European Medicines Agency)

krka, d.d., novo mesto - kapecitabin - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastiske midler - ecansya er indisert for adjuverende behandling av pasienter etter operasjon av stadium-iii (dukes 'stadium-c) tykktarmskreft. ecansya er angitt for behandling av metastatisk kolorektal kreft. ecansya er indikert for første-linje behandling av avansert magekreft i kombinasjon med et platinum-basert diett. ecansya i kombinasjon med docetaxel er indisert for behandling av pasienter med lokalt avansert eller metastatisk brystkreft etter svikt av cytotoksisk kjemoterapi. tidligere behandling bør ha inkludert en antracyklin. ecansya er også indisert som monoterapi for behandling av pasienter med lokalt avansert eller metastatisk brystkreft etter svikt av taxanes og en anthracycline inneholder kjemoterapi diett eller for hvem videre anthracycline terapi er ikke angitt.

Euroopan unioni - norja - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - karsinom, ikke-småcellet lunge - antineoplastiske midler - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Euroopan unioni - norja - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - antineoplastiske midler - erbitux er indisert for behandling av pasienter med epidermal vekstfaktor reseptor (egfr)-uttrykker, ras wild-type metastatisk kolorektal kreft:i kombinasjon med irinotecan-basert kjemoterapi;i første linje i kombinasjon med folfox;som en enkelt agent hos pasienter som har mislyktes oxaliplatin - og irinotecan-basert terapi og som er intolerante til irinotecan. for detaljer, se kapittel 5. erbitux er indisert for behandling av pasienter med plateepitelkreft kreft i hode og hals:i kombinasjon med strålebehandling for lokalt avansert sykdom, i kombinasjon med platinum-basert kjemoterapi for tilbakevendende og/eller metastatisk sykdom.

Euroopan unioni - norja - EMA (European Medicines Agency)

zoetis belgium sa - maropitantcitrat - fordøyelseskanalen og metabolisme - dogs; cats - tabletter hunder: for forebygging av kvalme indusert ved kjemoterapi. for å forebygge oppkast forårsaket av bevegelsessykdom. for forebygging og behandling av oppkast, i kombinasjon med cerenia injeksjonsvæske, oppløsning og i kombinasjon med andre støttende tiltak. løsning for injectiondogs:for behandling og forebygging av kvalme forårsaket av kjemoterapi. for å forebygge oppkast bortsett fra det som fremkalles av bevegelsessykdom. til behandling av oppkast, i kombinasjon med andre støttende tiltak. for forebygging av perioperative kvalme og oppkast og forbedring i utvinning av generell anestesi etter bruk av μ-opiat reseptor agonist morfin. katter: for å forebygge oppkast og redusere kvalme, unntatt det som fremkalles av bevegelsessykdom. til behandling av oppkast, i kombinasjon med andre støttende tiltak.

Euroopan unioni - norja - EMA (European Medicines Agency)

advanced accelerator applications - l-arginine hydrochloride, l-lysine hydrochloride - stråling skader - detoxifying agents for antineoplastic treatment - lysakare er indikert for reduksjon av nyre-stråling i løpet av peptid-reseptor radionuklide terapi (prrt) med lutetium (177lu) oxodotreotide i voksne.