Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mylan ire healthcare limited, Írsko - fentanyl - 65 - analgetica - anodyna

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mylan ire healthcare limited, Írsko - fentanyl - 65 - analgetica - anodyna

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinúria, paroxysmálna - selektívne imunosupresíva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mtp medical technical promotion gmbh take-off-gewerbepark 46 d-78579 neuhausen ob eck nemecko -

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mtp medical technical promotion gmbh take-off-gewerbepark 46 d-78579 neuhausen ob eck nemecko -

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mtp medical technical promotion gmbh take-off-gewerbepark 46 d-78579 neuhausen ob eck nemecko -

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mtp medical technical promotion gmbh take-off-gewerbepark 46 d-78579 neuhausen ob eck nemecko -

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

pharmanovia a/s, dánsko - Ópium - 49 - digestiva, adsorbentia, acida

Eiropas Savienība - slovāku - 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.

Slovākija - slovāku - ŠÚKL (Štátny ústav pre kontrolu liečiv)

g.l. pharma gmbh, rakúsko - fentanyl - 65 - analgetica - anodyna