Unia Europejska - duński - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrémidler, tarm antiinflammatorisk / antiinfective agenter - truberzi er indiceret hos voksne til behandling af irritabel tarmsyndrom med diarré (ibs d).

Unia Europejska - duński - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ombitasvir, paritaprevir, ritonavir - hepatitis c kronisk - antivirale midler til systemisk anvendelse - viekirax er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c (chc) hos voksne. for at hepatitis c virus (hcv) genotype specifikke aktivitet.

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

teva b.v. - voriconazol - pulver til infusionsvæske, opløsning - 200 mg

Unia Europejska - duński - 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).

Unia Europejska - duński - EMA (European Medicines Agency)

pfizer europe ma eeig - ritlecitinib tosilate - alopecia areata - immunosuppressiva - litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

Unia Europejska - duński - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. virkning af imatinib om resultatet af bone marrow transplantation er ikke fastlagt. imatinib actavis is indicated for: , 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 dfsp. erfaringerne med imatinib i patienter med mds/mpd, der er forbundet med pdgfr gen re-arrangementer er meget begrænset. der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme.

Unia Europejska - duński - EMA (European Medicines Agency)

h. lundbeck a/s - eptinezumab - migræneforstyrrelser - analgetika - vyepti is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

Unia Europejska - duński - EMA (European Medicines Agency)

amgen europe bv - sotorasib - carcinom, ikke-småcellet lunge - antineoplastiske midler - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

Unia Europejska - duński - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochlorid - vomiting; neoplasms; nausea; cancer - antiemetika og antinauseants, - akynzeo er angivet i voksne til forebyggelse af akut og forsinket kvalme og opkastning i forbindelse med meget emetogenic cisplatin-baseret kemoterapi mod kræft. forebyggelse af akut og forsinket kvalme og opkastning i forbindelse med moderat emetogenic kræft kemoterapi.

Unia Europejska - duński - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastiske midler - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.