Unia Europejska - szwedzki - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibakteriella medel för systemiskt bruk, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 och 5. hänsyn bör tas till officiella riktlinjer för lämplig användning av antibakteriella medel.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastiska medel - 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.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - antineoplastiska medel - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinom, non-small cell lung - antineoplastiska medel - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostata tumörer, kastrering-resistent - antineoplastiska medel - treatment of adult patients with prostate cancer.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastiska medel - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunsuppressiva - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

eli lilly nederland b.v. - pirtobrutinib - lymfom, mantelcell - protein kinas-hämmare - treatment of mantle cell lymphoma (mcl).

Unia Europejska - szwedzki - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multipelt myelom - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. i kombination med bortezomib, talidomid och dexametason för behandling av vuxna patienter med nyligen fått diagnosen multipelt myelom som är berättigade till autolog stamcellstransplantation. i kombination med lenalidomid och dexametason, eller bortezomib och dexametason, för behandling av vuxna patienter med multipelt myelom som har fått minst en tidigare behandling. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. som monoterapi för behandling av vuxna patienter med återfall och eldfasta multipelt myelom, vars tidigare behandling ingår en proteasom-hämmare och en immunmodulerande substans avsedd att fungera som agent och som har visat att de försämras i sin sjukdom på den sista terapi. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Unia Europejska - szwedzki - EMA (European Medicines Agency)

orion corporation - dexmedetomidine hydrochloride - bevisad sedation - neuroleptika - för sedering av vuxna intensivvårdspersoner som kräver en sederingsnivå inte djupare än upphetsning som svar på verbal stimulering (motsvarande richmond agitation-sedation scale (rass) 0 till -3).