האיחוד האירופי - סלובנית - 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 - antineoplastična sredstva - 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. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. 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. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

amivas ireland ltd - artesunate - malarija - antiprotozoals - artesunate amivas is indicated for the initial treatment of severe malaria in adults and children. upoštevati je treba uradne smernice za ustrezno uporabo proti malariji agenti.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

vetcare oy - medetomidine hydrochloride, vatinoxan hydrochloride - psiholeptiki, hipnotiki in sedativi - psi - to provide restraint, sedation and analgesia during conduct of non-invasive, non-painful or mildly painful procedures and examinations intended to last no more than 30 minutes.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin aspart - sladkorna bolezen - zdravila, ki se uporabljajo pri diabetesu - truvelog mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - imunosupresivi - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi, selektivno imunosupresivi - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

sandoz gmbh - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastična sredstva - treatment of metastatic and early breast cancer and metastatic gastric cancer (mgc).

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - clopidogrel (as hydrogen sulfate) - stroke; peripheral vascular diseases; myocardial infarction; acute coronary syndrome - antitrombotična sredstva - clopidogrel je navedeno pri odraslih za preprečevanje atherothrombotic dogodkov v:- bolnike, ki trpijo za miokardni infarkt (od nekaj dni do manj kot 35 dni), ischaemic kap (od 7 dni do manj kot 6 mesecev) ali sedež periferne arterijske bolezni. - bolniki, ki trpijo za akutni koronarni sindrom:non-st segmentu višinskih akutni koronarni sindrom (nestabilna angina pektoris ali ne-q-val, miokardni infarkt), vključno z bolniki, ki opravljajo stent umestitev po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilne kisline (asa). st segmentu višinskih akutni miokardni infarkt, v kombinaciji s asa v medicinsko zdravljenih bolnikih, ki izpolnjujejo pogoje za thrombolytic terapija.