Europeiska unionen - svenska - EMA (European Medicines Agency)

incline therapeutics europe ltd - fentanylhydroklorid - smärta, postoperativ - smärtstillande medel - ionsys är indicerat för hantering av akut måttlig till svår postoperativ smärta hos vuxna patienter.

Europeiska unionen - svenska - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - glykogenlagringssjukdomstyp ii - andra matsmältningsorgan och ämnesomsättning produkter, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Europeiska unionen - svenska - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - immunsuppressiva - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Europeiska unionen - svenska - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursorcell lymfoblastisk leukemi-lymfom - antineoplastiska medel - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

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)

pfizer europe ma eeig - gemtuzumab ozogamicin - leukemi, myeloid, akut - antineoplastiska medel - mylotarg är indicerat för kombinationsbehandling med daunorubicin (dnr) och cytarabin (arac) för behandling av patienter ålder 15 år och uppåt med tidigare obehandlad, de novo-cd33-positiv akut myeloisk leukemi (aml), utom akut promyeloisk leukemi (apl).

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

sigillata ltd - tadalafil - filmdragerad tablett - 5 mg - laktosmonohydrat hjälpämne; natriumlaurilsulfat hjälpämne; tadalafil 5 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

cipla europe nv - flutikasonpropionat; salmeterolxinafoat - inhalationsspray, suspension - 25 mikrogram/125 mikrogram/dos - flutikasonpropionat 125 mikrog aktiv substans; salmeterolxinafoat 36,32 mikrog aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

cipla europe nv - flutikasonpropionat; salmeterolxinafoat - inhalationsspray, suspension - 25 mikrogram/250 mikrogram/dos - salmeterolxinafoat 36,32 mikrog aktiv substans; flutikasonpropionat 250 mikrog aktiv substans