Evrópusambandið - sænska - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autolog cd34+ cell berikad befolkningen som innehåller hematopoetiska stamceller transduced med lentiglobin bb305 lentiviral vektor kodning beta-en-t87q-globingenen - beta-talassemi - other hematological agents - zynteglo är indicerat för behandling av patienter som är 12 år och äldre med transfusion är beroende av β-thalassemi (tdt) som inte har en β0/β0 genotyp, för vem hematopoietiska stamceller (hsc) transplantation är lämpliga, men en human leukocyte antigen (hla-matchade relaterade hsc givare är inte tillgängligt.

Evrópusambandið - sænska - EMA (European Medicines Agency)

cis bio international - ioflupan (123l) - radionuclide imaging; dementia; movement disorders - diagnostiska radioaktiva läkemedel - detta läkemedel är endast för diagnostisk användning. striascan anges för att upptäcka förlust av funktionell dopaminerga neuron terminaler i striatum:hos vuxna patienter med kliniskt osäker parkinsonistisk syndrom, till exempel personer med tidiga symtom, för att hjälpa till att skilja essentiell tremor från parkinsonistisk syndrom relaterat till idiopatisk parkinsons sjukdom, multipel systematrofi och progressiv supranukleär pares. striascan är inte att diskriminera mellan parkinsons sjukdom, multipel systematrofi och progressiv supranukleär pares. hos vuxna patienter, för att hjälpa till att skilja trolig demens med lewy organ från alzheimers sjukdom. striascan är inte att diskriminera mellan demens med lewy organ och parkinsons sjukdom, demens.

Evrópusambandið - sænska - EMA (European Medicines Agency)

evolus pharma b.v. - botulinum toxin typ a - hudens Åldrande - andra muskelavslappnande medel, perifert verkande medel - tillfällig förbättring i uppkomsten av måttlig till svår vertikala linjer mellan ögonbrynen sett på högsta rynkad panna (glabellar linjer), när svårighetsgraden av ovanstående ansikts linjer har en viktig psykologisk effekt hos vuxna under 65 års ålder.

Evrópusambandið - sænska - EMA (European Medicines Agency)

gilead sciences ireland uc - remdesivir - covid-19 virus infection - veklury is indicated for the treatment of coronavirus disease 2019 (covid 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

Evrópusambandið - sænska - 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.

Evrópusambandið - sænska - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vacciner - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Evrópusambandið - sænska - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - lymfom, mantelcell - antineoplastiska medel - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Evrópusambandið - sænska - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - diagnostiska radioaktiva läkemedel - detta läkemedel är endast för diagnostisk användning. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. hos vuxna patienter, för att hjälpa till att skilja trolig demens med lewy organ från alzheimers sjukdom.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

Evrópusambandið - sænska - 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).

Evrópusambandið - sænska - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vacciner - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.