Eiropas Savienība - zviedru - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinuri, paroxysmal - immunsuppressiva - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - glykogenlagringssjukdomstyp ii - andra matsmältningsorgan och ämnesomsättning produkter, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - andra matsmältningsorgan och ämnesomsättning produkter, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multipelt myelom - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Eiropas Savienība - zviedru - 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.

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminosyrametabolism, infödda fel - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - cytomegalovirusinfektioner - antivirala medel för systemisk användning - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). hänsyn bör tas till officiella riktlinjer för lämplig användning av antivirala medel.

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

sanofi b.v. - sutimlimab - hemolysis; anemia, hemolytic, autoimmune - immunsuppressiva - enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (cad).

Eiropas Savienība - zviedru - EMA (European Medicines Agency)

amryt pharmaceuticals dac - metreleptin - lipodystrofi, familjär delvis - andra matsmältningsorgan och ämnesomsättning produkter, - myalepta är indicerat som komplement till kost som en ersättning terapi för att behandla komplikationer av leptin brist i lipodystrofi (ld) patienter med konstaterad ärftlig allmänna ld (berardinelli-seip syndrom) eller förvärvade allmänna ld (lawrence syndrom) hos vuxna och barn som är 2 år och abovewith bekräftat familjär delvis ld eller förvärvade delvis ld (barraquer-simons syndrom) hos vuxna och barn från 12 år och uppåt som standard behandlingar har misslyckats med att uppnå en adekvat metabol kontroll.