Europeiska unionen - svenska - EMA (European Medicines Agency)

nanotherapeutics bohumil, s.r.o. - whole virion influenza vaccine, inactivated containing antigen of strain a/california/07/2009 (h1n1)v - disease outbreaks; influenza, human; immunization - vacciner - profylax av influensa orsakad av a (h1n1) v 2009 virus. celvapan bör användas i enlighet med officiella riktlinjer.

Europeiska unionen - svenska - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hydroklorid - kolorektala neoplasmer - antineoplastiska medel - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Europeiska unionen - svenska - EMA (European Medicines Agency)

molmed spa - allogena t celler genetiskt modifierad med en retrovirala vektor kodning för en stympad form av mänsklig låg affinitet nervtillväxtfaktor receptorn (Δlngfr) och den herpes simplex virus tymidinkinas (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastiska medel - zalmoxis indikeras som tilläggsbehandling vid haploidentisk hematopoetisk stamcellstransplantation (hsct) hos vuxna patienter med högriskhormatiska maligniteter.

Europeiska unionen - svenska - EMA (European Medicines Agency)

csl behring gmbh - human alpha1-proteinase inhibitor - genetic diseases, inborn; lung diseases - hemostatika - respreeza är indicerat för underhållsbehandling, för att sakta ned progressionen av emfysem hos vuxna med dokumenterad svår alfa1-proteinasinhibitorbrist (e. genotyper pizz, piz (null), pi (null, null), pisz). patienterna ska vara under optimal farmakologisk och icke-farmakologisk behandling och visa tecken på progressiv lungsjukdom (t.ex.. lägre forcerad exspiratorisk volym per sekund (fev1) förutspådde, nedsatt promenader kapacitet eller ökat antal exacerbationer) som utvärderats av sjukvårdspersonal med erfarenhet av behandling av alpha1-proteinas brist.

Europeiska unionen - svenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - tedizolid fosfat - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, , other antibacterials - sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and adolescents 12 years of age and older.

Europeiska unionen - svenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatit c, kronisk - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 och 5. för hepatit c-virus (hcv) av genotyp-specifik aktivitet (se avsnitt 4. 4 och 5.

Europeiska unionen - svenska - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - ceftaroline fosamil - community-acquired infections; skin diseases, infectious; pneumonia - antibakteriella medel för systemiskt bruk, - zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: , complicated skin and soft tissue infections (cssti), community-acquired pneumonia (cap) , consideration should be given to official guidance on the appropriate use of antibacterial agents.

Europeiska unionen - svenska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - hiv-infektioner - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza är indicerat för behandling av infektion hos human immunodeficiency virus type 1 (hiv-1) hos vuxna och ungdomar (12 år och äldre med en kroppsvikt på minst 40 kg). genotypic testing should guide the use of symtuza.

Europeiska unionen - svenska - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arsenik svaveltrioxid - leukemi, promyelocytisk, akut - antineoplastiska medel - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. svarsfrekvensen av andra akut myeloisk leukemi subtyper arsenik antimontrioxid har inte varit föremål för granskning.

Europeiska unionen - svenska - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - vacciner - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older. användning av detta vaccin bör ske i enlighet med officiella rekommendationer.