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

merck sharp & dohme b.v. - letermovir - cytomegalovirusinfeksjoner - antivirale midler til systemisk bruk - prevymis er indisert til profylakse cytomegalovirus (cmv) aktivering og sykdom i voksen cmv-avrusningsenhetene mottakere [r +] av en allogene haematopoietic stilk cellen transplantasjon (hsct). det bør vurderes å offisielle retningslinjer for riktig bruk av antivirale midler.

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

pharmaand gmbh - rucaparib camsylate - ovarie neoplasmer - antineoplastiske midler - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca er indisert som monoterapi for vedlikehold behandling av voksne pasienter med platinum-sensitive tilbakefall av høy klasse epithelial ovarian, egglederen, eller primær-peritoneal kreft som er i respons (hel eller delvis) til platinum-basert kjemoterapi.

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

pfizer europe ma eeig - lorlatinib - karsinom, ikke-småcellet lunge - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

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

bayer ag - larotrectinib sulfat - abdominal neoplasmer - antineoplastiske midler - vitrakvi som monoterapi er indisert for behandling av voksne og paediatric pasienter med solide svulster som viser en neurotrophic reseptor tyrosin kinase (ntrk) - genet fusion,som har en sykdom som er lokalt avansert eller metastatisk hvor kirurgisk reseksjon er sannsynlig å resultere i alvorlig sykelighet, andwho har ingen tilfredsstillende behandlingstilbud.

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

alfasigma s.p.a. - metyltioniniumklorid - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

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

nabriva therapeutics ireland dac - lefamulin acetate - pneumonia, bacterial; community-acquired infections - antibakterielle midler for systemisk bruk, - xenleta is indicated for the treatment of community-acquired pneumonia (cap) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of cap or when these have failed. det bør vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

Norge - norsk - Statens legemiddelverk

amdipharm limited (1) - erytromycinstearat - tablett, drasjert - 250 mg

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

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastiske midler - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

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

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastiske midler - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

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

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastiske midler - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pasienter som har en lav eller svært lav risiko for tilbakefall bør ikke får adjuvant behandling. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. bortsett fra i nydiagnostisert kronisk fase kml, det er ingen kontrollerte studier som viser en klinisk nytte eller økt overlevelse for disse sykdommer.