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

janssen-cilag international nv - bedaquilinfumarat - tuberkulose, multidrugt-resistent - antimyco-bakterielle midler - sirturo er indiceret til brug som en del af en passende kombination regime for pulmonal multidrug resistente tuberkulose (mdr-tb) hos voksne og unge patienter (12 år til mindre end 18 år, og som vejer mindst 30 kg), når en effektiv behandling regime ellers ikke kan være sammensat på grund af resistens eller tolerance. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

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

mylan pharmaceuticals limited - tenofovirdisoproxil - hiv infektioner - antivirale midler til systemisk anvendelse - hiv-1 infectiontenofovir disoproxil 245 mg filmovertrukne tabletter er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv-1 inficerede voksne. i voksne, demonstration af gavn af tenofovir disoproxil i hiv-1 infektion er baseret på resultaterne af en undersøgelse i behandling-naive patienter, herunder patienter med en høj virusmængde (> 100.000 kopier/ml) og undersøgelser, hvor tenofovir disoproxil blev tilføjet til stabil baggrund terapi (primært tritherapy) i antiretroviral pre-behandlede patienter oplever tidligt virologisk svigt (< 10.000 kopier/ml, med de fleste af de patienter, der har < 5.000 kopier/ml). tenofovir disoproxil 245 mg filmovertrukne tabletter er også indiceret til behandling af hiv-1-inficerede teenagere, med nrti modstand eller toksiciteter er til hinder for anvendelsen af første linje agenter, i alderen 12 - < 18 år. valget af tenofovir disoproxil til behandling af antiretroviral-erfarne patienter med hiv-1 infektion bør være baseret på individuelle viral resistens test og/eller historie behandling af patienter. hepatitis b infectiontenofovir disoproxil 245 mg filmovertrukne tabletter er indiceret til behandling af kronisk hepatitis b hos voksne med kompenseret leversygdom, med tegn på aktiv virusreplikation, vedvarende forhøjet serum-alanin aminotransferase (alt) niveauer og histologiske dokumentation for aktiv inflammation og/eller fibrose. dokumentation af lamivudin-resistente hepatitis b-virus. dekompenseret leversygdom. tenofovir disoproxil 245 mg filmovertrukne tabletter er indiceret til behandling af kronisk hepatitis b i 12 unge < 18 år med kompenseret leversygdom og dokumentation af aktive immun sygdom, har jeg. aktiv viral replikation, vedvarende forhøjet serum alt niveauer og histologiske dokumentation for aktiv inflammation og/eller fibrose.

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

sanofi b.v. - thyrotropin alfa - thyroid neoplasms - hypofyseforlaps lap hormoner og analoger, hypofyse og hypothalamus hormoner og analoger - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.

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

mylan ire healthcare limited - pretomanid - tuberkulose, multidrugt-resistent - antimyco-bakterielle midler - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

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

novartis europharm limited - crizanlizumab - anæmi, sickle cell - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

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

astrazeneca ab - acalabrutinib - leukæmi, lymfocytisk, kronisk, b-celle - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.

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

daiichi sankyo europe gmbh - trastuzumab deruxtecan - bryst neoplasmer - antineoplastiske midler - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

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

amgen europe bv - sotorasib - carcinom, ikke-småcellet lunge - antineoplastiske midler - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

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

sanofi b.v. - avalglucosidase alfa - glycogen opbevaring sygdom type ii - andre alimentary tract and metabolism produkter, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

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

sun pharmaceutical industries (europe) b.v. - ertapenemnatrium - bakterieinfektioner - ertapenem - treatmentertapenem sun is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4. 4 og 5. 1):- intra-abdominal infections- community acquired pneumonia- acute gynaecological infections- diabetic foot infections of the skin and soft tissue (see section 4. 4)preventionertapenem sun is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..