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

abbvie deutschland gmbh co. kg - venetoclax - leukemi, lymfocytisk, kronisk, b-celle - antineoplastiske midler - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

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

abbvie deutschland gmbh & co. kg - risankizumab - psoriasis; arthritis, psoriatic - immunsuppressive - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). crohn's diseaseskyrizi is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

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

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - antineoplastiske midler - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

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

pfizer europe ma eeig - parecoxibnatrium - smerte, postoperativ - coxibs, antiinflammatory and antirheumatic products - for kortsiktig behandling av postoperativ smerte hos voksne.

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

eli lilly nederland b.v. - abemaciclib - bryst neoplasms - antineoplastiske midler - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

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

idorsia pharmaceuticals deutschland gmbh - daridorexant hydrochloride - søvninitiasjon og vedlikeholdssykdommer - psykoleptiske - quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

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

nova laboratories ireland limited - spironolakton - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 og 5.

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

akcea therapeutics ireland limited - inotersen sodium - amyloidosis - andre nervesystemet narkotika - behandling av trinn 1 eller trinn 2 polynevropati hos voksne pasienter med arvelig transthyretin amyloidose (hattr).

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

sun pharmaceutical industries (europe) b.v. - ertapenemnatrium - bakterielle infeksjoner - 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 vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

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

insmed netherlands b.v. - amikacin sulfate - luftveisinfeksjoner - antibakterielle midler for systemisk bruk, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.