Europeiska unionen - svenska - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multipel skleros - selektiva immunsuppressiva medel - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 och 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Europeiska unionen - svenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - zoledronsyramonohydrat - hypercalcemia; fractures, bone; cancer - bisfosfonater - förebyggande av skelettrelaterade händelser (patologiska frakturer, ryggradskompression, strålning eller operation till ben eller tumörinducerad hyperkalcemi) hos vuxna patienter med avancerade maligniteter som involverar ben. behandling av vuxna patienter med tumör-inducerad hypercalcaemia (tih).

Europeiska unionen - svenska - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - formoterol fumarate dihydrate, glycopyrronium, beclometasone dipropionate - pulmonell sjukdom, kronisk obstruktiv - läkemedel mot obstruktiv lungsjukdom, - underhållsbehandling hos vuxna patienter med måttlig till svår kronisk obstruktiv lungsjukdom (kol) som inte behandlas på ett tillfredsställande sätt genom en kombination av en inhalerad kortikosteroid och en långverkande beta2-agonist (för effekter på symtom kontroll och förebyggande av exacerbationer se avsnitt 5.

Europeiska unionen - svenska - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - carcinom, non-small cell lung - antineoplastiska medel - alunbrig is indicated as monotherapy 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. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Europeiska unionen - svenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - multipelt myelom - antineoplastiska medel - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - tiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastiska medel - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Europeiska unionen - svenska - EMA (European Medicines Agency)

immunocore ireland limited - tebentafusp - uveal neoplasms - antineoplastiska medel - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Europeiska unionen - svenska - 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%.

Europeiska unionen - svenska - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofili b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Europeiska unionen - svenska - 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.