Evropska unija - švedščina - EMA (European Medicines Agency)

unigene uk ltd. - recombinant salmon calcitonin - hypercalcemia; osteitis deformans; bone resorption - calciumhomeostas - kalcitonin är indicerat för:förebyggande av akut förlust av benmassa på grund av plötsliga stoppet som i patienter med recentosteoporotic fracturespaget är diseasehypercalcaemia av malignitet.

Evropska unija - švedščina - EMA (European Medicines Agency)

dendreon uk ltd - autologa perifera blodmononukleära celler innefattande minst 50 miljoner autologa cd54 + -celler aktiverade med prostatisk syrafosfatasgranulocyt-makrofagkolonistimulerande faktor - prostatiska neoplasmer - andra immunostimulanter - provenge är indicerat för behandling av asymptomatisk eller minimalt symptomatisk metastatisk (icke-visceral) castratresistent prostatacancer hos manliga vuxna, i vilka kemoterapi ännu inte är kliniskt indikerad.

Evropska unija - švedščina - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - hypertension - agenter som verkar på renin-angiotensinsystemet - behandling av essentiell hypertoni.

Evropska unija - švedščina - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - carcinom, squamous cell - antineoplastiska medel - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Evropska unija - švedščina - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - multipel skleros, skovvis förlöpande - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Evropska unija - švedščina - EMA (European Medicines Agency)

amivas ireland ltd - artesunate - malaria - medel mot protozoer - artesunate amivas is indicated for the initial treatment of severe malaria in adults and children. hänsyn bör tas till officiella riktlinjer för korrekt användning av medel mot malaria.

Evropska unija - švedščina - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - respiratoriska syncytialvirusinfektioner - vacciner - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. användning av detta vaccin bör ske i enlighet med officiella rekommendationer.

Švedska - švedščina - Läkemedelsverket (Medical Products Agency)

vivisol srl - ikodextrin; kalciumkloriddihydrat; magnesiumkloridhexahydrat; natrium-(s)-laktatlösning; natriumklorid - peritonealdialysvätska - kalciumkloriddihydrat 257 mikrog aktiv substans; magnesiumkloridhexahydrat 51 mikrog aktiv substans; natriumklorid 5,4 mg aktiv substans; ikodextrin 75 mg aktiv substans; natrium-(s)-laktatlösning 9 mg aktiv substans

Evropska unija - švedščina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioödemar, ärftlig - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Evropska unija - švedščina - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektiva immunsuppressiva medel - ulcerös colitisentyvio är indicerat för behandling av vuxna patienter med måttlig till svår aktiv ulcerös kolit som har haft ett otillräckligt svar med, förlorade svar på, eller var intoleranta mot antingen konventionell terapi eller en tumor necrosis factor alfa (tnfa-receptorantagonist. crohns diseaseentyvio är indicerat för behandling av vuxna patienter med måttlig till svår aktiv crohns sjukdom som har haft ett otillräckligt svar med, förlorade svar på, eller var intoleranta mot antingen konventionell terapi eller en tumor necrosis factor alfa (tnfa-receptorantagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.