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

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanom - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

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

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastiske midler - brukinsa as monotherapy 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. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

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

astrazeneca ab - nirsevimab - immune sera og immunglobuliner, - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in neonates and infants during their first rsv season. beyfortus should be used in accordance with official recommendations.

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

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastiske midler - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq som monoterapi er indisert for behandling av voksne pasienter med lokalt avansert eller metastatisk nsclc etter før kjemoterapi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq som monoterapi er indisert for behandling av voksne pasienter med lokalt avansert eller metastatisk nsclc etter før kjemoterapi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

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

regeneron ireland designated activity company (dac) - cemiplimab - karsinom, squamous cell - antineoplastiske midler - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

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

glaxo group ltd. - flutikasonfuroat - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - nasale preparater - voksne, ungdom (12 år og eldre) og barn (6-11 år). alisade er indisert for behandling av symptomene på allergisk rhinitt.

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

menarini international operations luxembourg s.a. - pemetrexed dinatriumhemipentahydrat - carcinoma, non-small-cell lung; mesothelioma - antineoplastiske midler - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ciambra er indisert som monoterapi for vedlikehold behandling av lokalt avansert eller metastatisk ikke-liten celle lunge kreft annet enn overveiende plateepitelkreft histology hos pasienter med sykdommen har ikke kommet umiddelbart etter platinum-basert kjemoterapi. ciambra er indisert som monoterapi for den andre linjen behandling av pasienter med lokalt avansert eller metastatisk ikke-liten celle lunge kreft annet enn overveiende plateepitelkreft histology.

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

orion corporation - entakapon - parkinsonsykdom - anti-parkinson medisiner - entacapone angis som et supplement til standard forberedelser til levodopa / benserazide eller levodopa / carbidopa for bruk hos pasienter med parkinson's sykdom og slutten av dose motor svingninger, som ikke skal stabiliseres på kombinasjonene.

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

orion corporation - entakapon - parkinsonsykdom - anti-parkinson medisiner - entacapone angis som et supplement til standard forberedelser til levodopa / benserazide eller levodopa / carbidopa for bruk i voksen pasienter med parkinsons sykdom og slutten av dose motor svingninger, som ikke skal stabiliseres på kombinasjonene.

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

n.v. organon - nomegestrol acetat, estradiol - prevensjon - sex hormoner og modulatorer av genital systemet, - oral prevensjon.