Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - 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 - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy 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. abevmy 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 abevmy in combination with capecitabine. for ytterligere informasjon om her2-status, se avsnitt 5. abevmy, 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 other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, 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. abevmy, 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 vegf inhibitors or vegf receptor–targeted agents. abevmy 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. abevmy, 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.

Avrupa Birliği - Norveççe - 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.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

ratiopharm gmbh - paclitaxel - bryst neoplasms - antineoplastiske midler - pazenir monoterapi er indisert for behandling av metastatisk brystkreft hos voksne pasienter som har mislyktes i første-linje behandling for metastatisk sykdom og for hvem standard, anthracycline inneholder terapi er ikke angitt. pazenir i kombinasjon med carboplatin er angitt for det første-linje behandling av ikke-liten celle lunge kreft hos voksne pasienter som ikke er kandidater for potensielt kurativ kirurgi og/eller strålebehandling.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

les laboratoires servier - irinotecan anhydrous free-base - bukspyttkjertelblodsykdommer - antineoplastiske midler - behandling av metastatisk adenocarcinoma av bukspyttkjertelen, sammen med 5 fluorouracil (5 fu) og leucovorin (lv), i voksen pasienter som har kommet etter gemcitabine basert terapi.

Norveç - Norveççe - Statens legemiddelverk

baxter medical ab - bleomycinsulfat - pulver til injeksjons-/infusjonsvæske, oppløsning - 15000 ie

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - karsinom, ikke-småcellet lunge - antineoplastiske midler - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiske midler - zirabev i kombinasjon med fluoropyrimidine-basert kjemoterapi er indisert for behandling av voksne pasienter med metastatisk karsinom i tykktarm eller endetarm. zirabev i kombinasjon med paclitaxel er indikert for første-linje behandling av voksne pasienter med metastatisk brystkreft. for ytterligere informasjon om human epidermal vekstfaktor reseptor 2 (her2) status. zirabev, i tillegg til platinum-basert kjemoterapi, er indikert for første-linje behandling av voksne pasienter med inoperabel avansert og metastatisk eller tilbakevendende ikke-liten celle lunge kreft annet enn overveiende plateepitelkreft histology. zirabev i kombinasjon med interferon alfa-2a er indikert for første linje behandling av voksne pasienter med avansert og/eller metastatisk nedsatt celle kreft. zirabev, i kombinasjon med paclitaxel og cisplatin eller, alternativt, paclitaxel og topotecan hos pasienter som ikke får platinum terapi, er indisert for behandling av voksne pasienter med vedvarende, tilbakevendende, eller metastatisk karsinom i cervix.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - cedazuridine, decitabine - leukemi, myeloid - antineoplastiske midler - inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for standard induction chemotherapy.

Norveç - Norveççe - Statens legemiddelverk

abacus medicine a/s - paklitaksel - pulver til infusjonsvæske, suspensjon - 5 mg/ ml

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

bayer ag - sorafenib - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastiske midler - hepatocellulært carcinomanexavar er angitt for behandling av hepatocellulært karsinom. nedsatt celle carcinomanexavar er indisert for behandling av pasienter med avansert nedsatt cell carcinoma som har mislyktes før interferon-alfa eller interleukin-2 basert terapi eller som er vurdert uegnet for slik behandling. differensiert skjoldbrusk carcinomanexavar er indisert for behandling av pasienter med progressiv, lokalt avansert eller metastatisk, differensiert (papillar/follicular/hürthle celle) skjoldbrusk carcinoma, refraktære til radioaktivt jod.