Norge - norsk - Statens legemiddelverk

ge healthcare b.v. - fludeoksyglukose (18f) - injeksjonsvæske, oppløsning - 250 mbq/ ml

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

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - antineoplastiske midler - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

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)

celgene europe bv - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - azacitidine celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification,aml with >30% marrow blasts according to the who classification.

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

betapharm arzneimittel gmbh - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - azacitidine betapharm er indisert for behandling av voksne pasienter som ikke er kvalifisert for haematopoietic stilk cellen transplantasjon (hsct) med:middels-2 og høy-risiko myelodysplastic syndromer (mds) i henhold til den internasjonale prognostiske scoring system (ipss),kronisk progenitorceller leukemi (cmml) med 10 % til 29 % marg sprenger uten myeloproliferativ sykdom,akutt myelogen leukemi (aml) med 20 % til 30 % eksplosjoner og multi-avstamning dysplasi, ifølge verdens helseorganisasjon (who) klassifisering,aml med > 30 % marg eksplosjoner i henhold til who-klassifisering.

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

mylan ireland limited - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

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

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - azacitidine accord er indisert for behandling av voksne pasienter som ikke er kvalifisert for haematopoietic stilk cellen transplantasjon (hsct) med:- middels-2 og høy-risiko myelodysplastic syndromer (mds) i henhold til den internasjonale prognostiske scoring system (ipss),- kronisk progenitorceller leukemi (cmml) med 10-29 % marg sprenger uten myeloproliferativ sykdom,- akutt myelogen leukemi (aml) med 20-30 % eksplosjoner og multi-avstamning dysplasi, ifølge verdens helseorganisasjon (who) klassifisering,- aml med >30% marg eksplosjoner i henhold til who-klassifisering.

Norge - norsk - Statens legemiddelverk

stada arzneimittel ag - azacitidin - pulver til injeksjonsvæske, suspensjon - 25 mg/ ml

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

accord healthcare s.l.u. - apixaban - venous thromboembolism; stroke; arthroplasty - antithrombotic agents - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. forebygging av slag og systemisk emboli hos voksne pasienter med ikke-valvulær atrieflimmer (nvaf), med én eller flere risikofaktorer, slik som tidligere hjerneslag eller forbigående ischaemic angrep (tia); alder ≥ 75 år, hypertensjon; diabetes mellitus; symptomatisk hjertesvikt (nyha klasse ≥ ii). behandling av dyp venetrombose (dvt) og lungeemboli (pe), og forebygging av tilbakevendende dvt og pe i voksne (se kapittel 4. 4 for haemodynamically ustabil pe pasienter). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). behandling av dyp venetrombose (dvt) og lungeemboli (pe), og forebygging av tilbakevendende dvt og pe i voksne (se kapittel 4. 4 for haemodynamically ustabil pe pasienter).

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.