Den europeiske union - norsk - EMA (European Medicines Agency)

the medicines company uk ltd - bivalirudin - akutt koronarsyndrom - antithrombotic agents - angiox er indisert som antikoagulant hos voksne pasienter som gjennomgår perkutan koronar intervensjon (pci), inkludert pasienter med st-segment-forhøyet myokardinfarkt (stemi) under primær pci. angiox er også indisert for behandling av voksne pasienter med ustabil angina / ikke-st-segment-elevation myocardial infarction (ua / nstemi) planlagt for påtrengende eller tidlig intervensjon. angiox bør administreres med acetylsalisylsyre og klopidogrel.

Den europeiske union - norsk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv-infeksjoner - antivirale midler til systemisk bruk - darunavir, 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 (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):for behandling av hiv-1-infeksjon i antiretroviral behandling (art)-erfarne voksne pasienter, inkludert de som har vært svært pre-behandlet. for behandling av hiv-1-infeksjon i paediatric pasienter fra fylte 3 år og minst 15 kg kroppsvekt. i de bestemmer seg for å starte behandling med darunavir co-gis med lav dose ritonavir, nøye vurdering bør gis til behandling historie av den enkelte pasient og mønstre av mutasjoner assosiert med ulike aktører. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 og 5. darunavir co-gis med lav dose ritonavir er indisert i kombinasjon med andre antiretroviral legemidler for behandling av pasienter med humant immunsviktvirus (hiv-1) infeksjon.  darunavir 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) (see section 4.  darunavir mylan 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 (see section 4.  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. i de bestemmer seg for å starte behandling med darunavir i en slik art-erfarne pasienter, genotypic testing bør veilede bruk av darunavir (se kapittel 4. 2, 4. 3, 4. 4 og 5.

Den europeiske union - norsk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide hydrochloride - trombocytemi, essensielt - antineoplastiske midler - anagrelide er indikert for reduksjon av forhøyet platederivert teller i fare viktig thrombocythaemia (et) pasienter som er intolerante til deres nåværende terapi eller som har forhøyet platederivert teller ikke reduseres til et akseptabelt nivå ved deres nåværende terapi. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

Den europeiske union - norsk - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karsinom, squamous cell - antineoplastiske midler - 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.

Norge - norsk - Statens legemiddelverk

the simple pharma company limited - testosteron - transdermalgel - 20 mg/ g

Den europeiske union - norsk - 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 - vaksiner - 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.

Den europeiske union - norsk - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - tiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastiske midler - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Den europeiske union - norsk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - cytomegalovirusinfeksjoner - antivirale midler til systemisk bruk - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). det bør vurderes å offisielle retningslinjer for riktig bruk av antivirale midler.

Den europeiske union - norsk - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatide - osteoporosis; osteoporosis, postmenopausal - kalsiumhomeostase - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Den europeiske union - norsk - 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 - respiratorisk syncytialvirusinfeksjoner - vaksiner - 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. bruk av denne vaksinen skal være i samsvar med offisielle anbefalinger.