Європейський Союз - словацька - EMA (European Medicines Agency)

mylan ireland limited - azacitidín - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastické činidlá - 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.

Європейський Союз - словацька - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidín - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastické činidlá - azacitidine dohode je indikovaný na liečbu dospelých pacientov, ktorí nie sú oprávnené na hematopoetickú kmeňových buniek transplantácia (hsct) s:- intermediate-2 a s vysokým rizikom myelodysplastic syndrómy (mds) podľa medzinárodného prognostického systému hodnotenia (ipss),- chronické myelomonocytic leukémia (cmml) s 10-29 % drene výbuchy bez myeloproliferative poruchy,- akútna myeloidná leukémia (aml) s 20-30 % výbuchy a multi-pôvod dysplázia, podľa svetovej zdravotníckej organizácie (who), klasifikácia,- boj proti praniu špinavých peňazí s >30% dreň výbuchy podľa who klasifikácie.

Європейський Союз - словацька - EMA (European Medicines Agency)

stemline therapeutics b.v. - tagraxofusp - lymphoma - antineoplastické činidlá - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

Європейський Союз - словацька - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - roztrúsená skleróza - selektívne imunosupresíva - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 a 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Європейський Союз - словацька - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresíva - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 a 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Європейський Союз - словацька - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinúria, paroxysmálna - imunosupresíva - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.

Європейський Союз - словацька - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - viacnásobný myelóm - antineoplastické činidlá - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Європейський Союз - словацька - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - všetky ostatné terapeutické produkty - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.