Suède - suédois - Läkemedelsverket (Medical Products Agency)

prothya biosolutions netherlands b.v - immunglobulin, humant normalt, för intravenös administrering - infusionsvätska, lösning - 100 mg/ml - glukosmonohydrat hjälpämne; immunglobulin, humant normalt, för intravenös administrering 100 mg aktiv substans

Union européenne - suédois - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinala stromaltumörer - andra antineoplastiska medel, protein kinas-hämmare - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Union européenne - suédois - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - infektioner i luftvägarna - antibakteriella medel för systemiskt bruk, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Union européenne - suédois - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - andra nervsystemet droger - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Union européenne - suédois - 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.

Union européenne - suédois - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinala stromaltumörer - antineoplastiska medel - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Union européenne - suédois - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirala medel för systemisk användning - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 och 5. tecovirimat siga should be used in accordance with official recommendations.

Suède - suédois - Läkemedelsverket (Medical Products Agency)

prothya biosolutions netherlands b.v - koagulationsfaktor ii, human; koagulationsfaktor ix, human; koagulationsfaktor vii, human; koagulationsfaktor x, human; protein c, humant; protein s, humant - pulver och vätska till injektionsvätska, lösning - 250 ie - protein s, humant 10 - 80 ie aktiv substans; koagulationsfaktor x, human 140 - 350 ie aktiv substans; koagulationsfaktor ix, human 250 ie aktiv substans; koagulationsfaktor vii, human 70 - 200 ie aktiv substans; protein c, humant 110 - 390 ie aktiv substans; koagulationsfaktor ii, human 140 - 350 ie aktiv substans

Suède - suédois - Läkemedelsverket (Medical Products Agency)

prothya biosolutions netherlands b.v - koagulationsfaktor ii, human; koagulationsfaktor ix, human; koagulationsfaktor vii, human; koagulationsfaktor x, human; protein c, humant; protein s, humant - pulver och vätska till injektionsvätska, lösning - 500 ie - koagulationsfaktor ii, human 280 - 700 ie aktiv substans; koagulationsfaktor vii, human 140 - 400 ie aktiv substans; koagulationsfaktor ix, human 500 ie aktiv substans; koagulationsfaktor x, human 280 - 700 ie aktiv substans; protein c, humant 220 - 780 ie aktiv substans; protein s, humant 20 - 160 ie aktiv substans

Union européenne - suédois - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - immunsuppressiva - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).