Európska únia - slovenčina - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastické činidlá - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacienti, ktorí majú nízky alebo veľmi nízke riziko opakovania by nemalo prijímať adjuvantná liečba. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. okrem novo diagnostikovaných chronickej fáze cml, nie sú tam žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení.

Európska únia - slovenčina - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskulárna blokáda - všetky ostatné terapeutické produkty - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Európska únia - slovenčina - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - sugammadex sodium - neuromuskulárna blokáda - všetky ostatné terapeutické produkty - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Európska únia - slovenčina - EMA (European Medicines Agency)

biomarin international limited - valoctocogene roxaparvovec - antihemoragiká - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Európska únia - slovenčina - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskulárna blokáda - všetky ostatné terapeutické produkty - zvrat neuromuskulárnej blokády indukovanej rokurónom alebo vekuróniom. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Európska únia - slovenčina - EMA (European Medicines Agency)

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - antitrombotické činidlá - prevention of venous thromboembolic events.

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

g.l. pharma gmbh, rakúsko - dabigatránetexilát - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

g.l. pharma gmbh, rakúsko - dabigatránetexilát - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

g.l. pharma gmbh, rakúsko - dabigatránetexilát - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Európska únia - slovenčina - EMA (European Medicines Agency)

piramal critical care b.v. - sugammadex sodium - neuromuskulárna blokáda - sugammadex - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.