Den Europæiske Union - dansk - 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 er indiceret til behandling af infektion med human immunodeficiency virus type 1 (hiv-1) hos voksne og unge (i alderen 12 år og ældre med kropsvægt mindst 40 kg). genotypic testing should guide the use of symtuza.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

almirall s.a - tildrakizumab - psoriasis - immunosuppressants, interleukin-hæmmere, - ilumetri er indiceret til behandling af voksne med moderat til svær plaque psoriasis, der er kandidater til systemisk terapi.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig  - crisaborole - dermatitis, atopisk - andre dermatologiske præparater - staquis er indiceret til behandling af mild til moderat atopisk dermatitis hos voksne og pædiatriske patienter fra 2 år med ≤ 40% legemsoverflade (bsa), der berøres.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - multipel sklerose, recidiverende-remitterende - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

eigerbio europe limited - lonafarnib - progeria; laminopathies - andre alimentary tract and metabolism produkter, - zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of hutchinson-gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous lmna mutation with progerin-like protein accumulation or a homozygous or compound heterozygous zmpste24 mutation.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - carcinom, ikke-småcellet lunge - antineoplastiske midler - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppressiva - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

bpl bioproducts laboratory gmbh - human koagulationsfaktor x - faktor x-mangel - vitamin k and other hemostatics, antihemorrhagics, coagulation factor x - coagadex er indiceret til behandling og profylakse af blødninger episoder og for perioperative management hos patienter med arvelig faktor x mangel. coagadex er angivet i alle aldersgrupper.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig - crizotinib - carcinom, ikke-småcellet lunge - antineoplastiske midler - xalkori as monotherapy is indicated for:the first‑line treatment of adults with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with previously treated anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with ros1‑positive advanced non‑small cell lung cancer (nsclc)the treatment of paediatric patients (age ≥6 to.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - andre antihypertensiva - behandling af pulmonal arteriel hypertension (pah) for at forbedre træningskapacitet og symptomer hos patienter med who-funktionsklasse iii. effekten har været vist i:primær (idiopatisk og familiær) pah;pah er sekundære i forhold til sklerodermi uden væsentlig interstitiel lungesygdom;pah associeret med medfødte systemisk-til-pulmonal shunt og eisenmenger ' s fysiologi. nogle forbedringer har også været vist i patienter med pah, der funktionelle klasse ii. stayveer er også angivet til at reducere antallet af nye digitale mavesår hos patienter med systemisk sklerose og løbende digital-ulcus sygdom.