Europeiska unionen - svenska - EMA (European Medicines Agency)

recordati rare diseases - osilodrostat fosfat - cushing syndrom - kortikosteroider för systemisk användning - isturisa är indicerat för behandling av endogena cushings syndrom hos vuxna.

Europeiska unionen - svenska - EMA (European Medicines Agency)

novartis europharm limited  - onasemnogene abeparvovec - muskelatrofi, ryggrad - andra droger för sjukdomar i muskel-skelettsystemet - zolgensma är indicerat för behandling av: - patienter med 5q spinal muskelatrofi (sma) med en bi-genetisk mutation i smn1-genen och en klinisk diagnos av sma typ 1, orpatients med 5q sma med en bi-genetisk mutation i smn1-genen och upp till 3 kopior av den gen smn2.

Europeiska unionen - svenska - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - multipelt myelom - antineoplastiska medel - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.

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)

mylan ire healthcare limited - pretomanid - tuberkulos, multidrug-resistent - medel mot mykobakterier - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). hänsyn bör tas till officiella riktlinjer för lämplig användning av antibakteriella medel.

Europeiska unionen - svenska - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemi, sickle cell - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Europeiska unionen - svenska - EMA (European Medicines Agency)

stemline therapeutics b.v. - tagraxofusp - lymphoma - antineoplastiska medel - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

Europeiska unionen - svenska - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - emapalumab - immune system diseases - gamifant is indicated for the treatment of paediatric patients aged under 18 years with primary haemophagocytic lymphohistiocytosis (hlh).

Europeiska unionen - svenska - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - andra nervsystemet droger - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Europeiska unionen - svenska - 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.