União Europeia - sueco - 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.

União Europeia - sueco - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infektioner - antivirala medel för systemisk användning - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

União Europeia - sueco - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. (miol) - ranolazin - angina pectoris - hjärtbehandling - ranexa är indicerad som tilläggsterapi för symptomatisk behandling av patienter med stabil angina pectoris som är otillräckligt kontrollerade eller intoleranta mot första linjens antianginala terapier (såsom betablockerare eller kalciumantagonister).

União Europeia - sueco - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - upadacitinib - artrit, reumatoid - immunsuppressiva - rheumatoid arthritisrinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (dmards). rinvoq may be used as monotherapy or in combination with methotrexate. psoriatic arthritisrinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more dmards. rinvoq may be used as monotherapy or in combination with methotrexate. axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri), who have responded inadequately to nonsteroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. atopic dermatitisrinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. ulcerative colitisrinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  crohn’s diseaserinvoq is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

União Europeia - sueco - EMA (European Medicines Agency)

pfizer europe ma eeig  - crisaborole - dermatit, atopisk - andra dermatologiska preparat - staquis är indicerat för behandling av mild till måttlig atopisk dermatit hos vuxna och pediatriska patienter från 2 års ålder ≤ 40% av kroppsytan (bsa) som påverkas.

União Europeia - sueco - EMA (European Medicines Agency)

merck sharp & dohme b.v. - daptomycin - gram-positive bacterial infections; bacteremia; soft tissue infections; endocarditis, bacterial - antibakteriella medel för systemiskt bruk, - cubicin är indicerat för behandling av följande infektioner. vuxna och pediatriska patienter (1 till 17 år) patienter med komplicerade hud-och infektioner i mjukvävnad (cssti). vuxna patienter med högersidig infektiös endokardit (rie) på grund av staphylococcus aureus. det rekommenderas att beslutet att använda daptomycin bör ta hänsyn till den antibakteriella mottaglighet av organismen och bör baseras på expert råd. vuxna och pediatriska patienter (1 till 17 år) patienter med staphylococcus aureus bacteraemia (sab). på vuxna, använder i bacteraemia bör i samband med rie eller med cssti, medan det i pediatriska patienter, använd i bacteraemia bör i samband med cssti. daptomycin är aktivt mot gram-positiva bakterier. i blandade infektioner där gram negativa och/eller vissa typer av anaeroba bakterier är misstänkta, cubicin ska vara samförvaltas med lämpligt antibakteriellt(s). hänsyn bör tas till officiella riktlinjer för lämplig användning av antibakteriella medel.

União Europeia - sueco - EMA (European Medicines Agency)

theravance biopharma ireland umited - telavancin - pneumonia, bacterial; cross infection - antibakteriella medel för systemiskt bruk, - vibativ är indicerat för behandling av vuxna med nosokomial pneumoni inklusive ventilatorassocierad pneumoni, känd eller misstänkt vara orsakade av meticillinresistenta staphylococcus aureus (mrsa). vibativ bör endast användas i situationer där det är känt eller misstänks att andra alternativ inte lämplig. hänsyn bör tas till officiella riktlinjer för lämplig användning av antibakteriella medel.

União Europeia - sueco - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

União Europeia - sueco - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - pomalidomide - multipelt myelom - immunsuppressiva - imnovid i kombination med bortezomib och dexametason är indicerat för behandling av vuxna patienter med multipelt myelom som har fått minst en tidigare behandlingsregim inklusive lenalidomid. imnovid i kombination med dexametason är indicerat för behandling av vuxna patienter med recidiverande och refraktärt multipelt myelom som har fått minst två tidigare behandlingsregimer, inklusive både lenalidomid och bortezomib, och har visat sjukdomsprogression efter den senaste behandlingen.

União Europeia - sueco - EMA (European Medicines Agency)

ipsen pharma - mecasermin - larons syndrom - hypofysiska och hypotalamiska hormoner och analoger - för långsiktig behandling av tillväxtfel hos barn och ungdomar med allvarlig primär insulinsliknande tillväxtfaktor-1-brist (primär igfd). svår primär igfd definieras av:höjd standard deviation score ≤ -3. 0, basal insulin-like growth factor-1 (igf-1) nivåer under 2. 5: e percentilen för ålder och kön och tillväxthormon (gh) är tillräckliga, utestängning av sekundära former av igf-1 brist, såsom undernäring, hypotyreos, eller kronisk behandling med farmakologiska doser av antiinflammatoriska steroider. svår primär igfd inkluderar patienter med mutationer i gh-receptorn (ghr), post-ghr signalväg, och igf-1-genen fel; de är inte gh brist, och de kan därför inte förväntas att hantera exogena gh-behandling. det rekommenderas att bekräfta diagnosen genom att göra ett igf-1 generationens test.