Den Europæiske Union - svensk - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskulär blockade - alla andra terapeutiska produkter - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Den Europæiske Union - svensk - 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).

Den Europæiske Union - svensk - 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.

Den Europæiske Union - svensk - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin aspart - diabetes mellitus - läkemedel som används vid diabetes - truvelog mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

Den Europæiske Union - svensk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multipel skleros, skovvis förlöpande - immunsuppressiva - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Den Europæiske Union - svensk - 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).

Den Europæiske Union - svensk - EMA (European Medicines Agency)

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - andra nervsystemet droger - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Den Europæiske Union - svensk - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasis - immunsuppressiva - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Den Europæiske Union - svensk - 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.

Den Europæiske Union - svensk - EMA (European Medicines Agency)

orphelia pharma sas - klofarabin - prekursorcell lymfoblastisk leukemi-lymfom - antineoplastiska medel - behandling av akut lymfatisk leukemi (all) hos pediatriska patienter som har recidiverat eller är refraktärt efter att ha fått minst två tidigare behandlingar och där finns det ingen annan behandlingsalternativ förväntas resultera i en varaktig respons. säkerhet och effekt har utvärderats i studier av patienter ≤ 21 år vid första diagnosen.