الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti. .

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - лопинавир, ritonavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - lopinavir/ritonavir je indiciran u kombinaciji s druge antiretrovirusne lijekove za liječenje humane imunodeficijencije (hiv-1) zaraženih odraslih, adolescenata i djece starosne dobi od 2 godine. izbor лопинавир/ritonavir za liječenje inhibitor proteaze iskusni hiv-1-inficiranih pacijenata mora se temeljiti na individualnoj virusne rezistencije ispitivanje i liječenje pacijenata.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - drugi antihipertenzivi sredstva - liječenje plućne arterijske hipertenzije (pah) za poboljšanje sposobnosti vježbanja i simptoma u bolesnika s funkcionalnom klasom svjetske zdravstvene organizacije (who) iii. učinkovitost je prikazan u:primarna (idiopatska i nasljedna) fuj;fuj sekundarne склеродермии bez značajnog интерстициальные bolesti pluća;lag, povezana sa urođenim sistem-na-plućna шунтов i eisenmenger fiziologije. neka poboljšanja su također je prikazano u bolesnika s lag, koji funkcionalna klasa ii. stayveer također je istakao smanjenje broja novih digitalne ulkusa kod pacijenata sa sistemske склеродермией i stalnom digitalni-peptičkog ulkusa.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

ge healthcare as - perflutren - ehokardiografija - kontrastni medij - ovaj je lijek samo za dijagnostičku uporabu. optison je транспульмональная эхокардиографическое kontrastno sredstvo za primjenu kod bolesnika s potencijalnim ili instaliran srčanih i krvožilnih bolesti, kako bi se osiguralo контрастирование kamere srca, povećanje lijeve klijetke-эндокарда-делимитация granice dovodi do poboljšanja zid-pokret za vizualizaciju. optison treba koristiti samo u bolesnika u kojih je studija bez kontrasta pojačanje je неокончательным.

كرواتيا - الكرواتية - HALMED (Agencija za lijekove i medicinske proizvode)

fresenius kabi d.o.o., radnička cesta 37a, zagreb, hrvatska - natrijev klorid - otopina za infuziju - 9 mg/ml - urbroj: 1 ml otopine sadrži 9 miligrama natrijevog klorida

كرواتيا - الكرواتية - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

pharmaq as, skogmo industriområde, industrivegen 50, 7863 overhalla, norveška - inaktivirani virus encefalopatije i retinopatije (engl. red-spotted grouper nervous necrosis virus, rgnnv) soj alv1107 - emulzija za injekciju - inaktivirani virus encefalopatije i retinopatije (engl. red-spotted grouper nervous necrosis virus, rgnnv) soj alv1107 - lubina (dicentrarchus labrax l)

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

ucb pharma s.a.   - fenfluramine hydrochloride - epilepsies, myoclonic - antiepileptici sredstva, - treatment of seizures associated with dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

koanaa healthcare gmbh - иматиниба мезилат - 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. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. 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. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - antineoplastična sredstva - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.