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

accord healthcare s.l.u. - cinacalcet hydroklorid - hyperparathyroidism - kalsiumhomeostase - sekundær hyperparathyroidismadultstreatment av sekundær hyperparathyroidism (hpt) hos voksne pasienter med end-stage renal disease (esrd) på vedlikehold dialyse terapi. paediatric populationtreatment av sekundær hyperparathyroidism (hpt) hos barn i alderen 3 år og eldre med end-stage renal disease (esrd) på vedlikehold dialyse behandling som sekundær hpt ikke er tilstrekkelig kontrollert med standarden på omsorg terapi (se kapittel 4. cinacalcet accordpharma kan brukes som en del av en terapeutisk regime inkluderer fosfat permer og/eller vitamin d sterols som er aktuelt (se punkt 5.. parathyroid karsinom og primary hyperparathyroidism i adultsreduction av hyperkalsemi hos voksne pasienter med:parathyroid carcinoma. primære hpt for hvem parathyroidectomy ville være angitt på grunnlag av serum kalsium nivåer (som definert av relevante retningslinjer for behandling), men i hvem parathyroidectomy er ikke klinisk relevant eller er kontraindisert.

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

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

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

bristol-myers squibb pharma eeig - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.

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

gsk vaccines s.r.l. - ytre membran blemmer fra neisseria meningitidis gruppe b (belastning nz 98/254), rekombinant neisseria meningitidis gruppe b fhbp fusion protein, rekombinant neisseria meningitidis gruppe b nada protein, rekombinant neisseria meningitidis gruppe b nhba fusion protein - meningitt, meningokokk - meningokokker-vaksiner - aktiv immunisering mot invasiv sykdom forårsaket av neisseria meningitidis serogruppe-b-stammer.

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

accord healthcare s.l.u. - caspofunginacetat - candidiasis; aspergillosis - antimykotika for systemisk bruk - behandling av invasiv candidiasis i voksen eller paediatric pasienter. behandling av invasive aspergillosis i voksen eller paediatric pasienter som er refraktære til eller intolerante av amfotericin b, lipid formuleringer av amfotericin b og/eller itrakonazol. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. empirisk behandling for antatte fungal infeksjoner (for eksempel candida eller aspergillus) i febrile, neutropaenic voksen eller paediatric pasienter.

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

sanofi b.v. - agalsidase beta - fabry sykdom - andre alimentary tract and metabolism products, - fabrazyme er indisert for langsiktig enzymutskiftningsterapi hos pasienter med en bekreftet diagnose av fabrys sykdom (a-galaktosidase-a-mangel).

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

accord healthcare s.l.u. - memantinhydroklorid - alzheimers sykdom - andre anti-demens medisiner - behandling av pasienter med moderat til alvorlig alzheimers sykdom.

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

mylan ireland limited - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

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

merck sharp & dohme b.v.  - imipenem monohydrat, cilastatin natrium, relebactam monohydrat - gram-negative bakterielle infeksjoner - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4. 4 og 5. - treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults. - treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4. 2, 4. 4 og 5. det bør vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

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

accord healthcare s.l.u. - degarelix acetate - prostata neoplasmer - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.