Rituzena (previously Tuxella) Europska Unija - hrvatski - EMA (European Medicines Agency)

rituzena (previously tuxella)

celltrion healthcare hungary kft. - rituksimab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastična sredstva - rituzena navodi u odraslih prema sljedećim kriterijima:неходжкинские limfoma (nhl)rituzena indiciran za liječenje nisu prethodno tretirani za liječenje bolesnika sa iii faze i. фолликулярная limfom u kombinaciji s kemoterapijom. rituzena monoterapija namijenjen je za liječenje bolesnika sa iii fazi u iv folikularni limfoma, koji su Хемо-aksijalni ili drugi ili naknadne recidiva nakon kemoterapije. rituzena indiciran za liječenje bolesnika s cd20 pozitivne difuzno крупноклеточной b u staničnim ne-ходжкинских лимфом u kombinaciji sa chop (ciklofosfamid, doksorubicin, vinkristin, prednizon) kemoterapija. kronične limfocitne leukemije (ХЛЛ)rituzena u kombinaciji s kemoterapijom što je prikazano za obradu bolesnika prethodno liječenih liječenje i relapsed/тугоплавким ХЛЛ. postoje samo ograničeni podaci o učinkovitosti i sigurnosti bolesnika prethodno liječenih monoklonsko antitijelo, uključujući rituzenaor bolesnika, vatrostalne standardnim tretmanima na prethodnu rituzena plus kemoterapija. Гранулематоз s полиангиитом i mikroskopskoj polyangiitisrituzena, u kombinaciji s s glukokortikoidi propisan za indukciju remisije kod odraslih pacijenata s teškim aktivnim гранулематоз s полиангиитом (wegener) (hpa) i микроскопическим полиангиитом (mpa).

Imatinib Actavis Europska Unija - hrvatski - EMA (European Medicines Agency)

imatinib actavis

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib actavis is indicated for: , 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. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Imatinib Teva Europska Unija - hrvatski - EMA (European Medicines Agency)

imatinib teva

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib-tewa indiciran za liječenje ofadult i pedijatrijska bolesnika s je prvi put dijagnosticiran Филадельфийской hromozoma (na bcr‑abl), koji je pozitivan (ph+) kronične mijeloične leukemije (kml), za koje je transplantacija koštane srži ne smatra se kao prva linija liječenja. za odrasle i pedijatrijska bolesnika s ph+ kml u fazi kroničnog neučinkovitosti interferon‑alfa terapija, ili u ubrzanu fazu ili бластного kriza. i pedijatrijski bolesne odrasle osobe s prvi put utvrđenom pozitivnom akutne limfoblastične leukemije Филадельфийская kromosom (ph+ all) u kombinaciji s kemoterapijom. za odrasle pacijenata s relaps ili vatrostalne ph+ all u monoterapiji. odraslih pacijenata s миелодиспластический/миелопролиферативными bolesti (mds/rafinerija), povezanim sa бляшк-выведенное ako uređaj primatelja faktor rasta (pdgfr) promjena u kromosomu preustroj. kod odraslih pacijenata sa sindromom napredno гиперэозинофильный (hes) i/ili kronične eozinofilni leukemije (osobe) sa fip1l1-pdgfra preokret. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib teva 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.

Arzerra Europska Unija - hrvatski - EMA (European Medicines Agency)

arzerra

novartis europharm ltd - ofatumumab - leukemija, limfocitna, kronična, b-stanica - monoklonska protutijela - ranije леченным kroničnim лимфолейкозом (ХЛЛ): vlasnika u kombinaciji s хлорамбуцилом ili бендамустин indiciran za liječenje bolesnika s ХЛЛ, koji nije dobio pre tretmana i koji nemaju pravo na флударабин-terapija. ponavljanje ХЛЛ: vlasnik je navedeno u kombinaciji s флударабином i циклофосфаном za liječenje odraslih pacijenata s relaps ХЛЛ. Рефрактерным ХЛЛ: vlasnik je indiciran za liječenje ХЛЛ kod pacijenata koji резистентны na флударабина i алемтузумаб.

Faslodex Europska Unija - hrvatski - EMA (European Medicines Agency)

faslodex

astrazeneca ab - fulvestrant od - neoplazme dojki - endokrini terapija, anti-estrogeni - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. u pre - ili perimenopauzi, u sveobuhvatnoj liječenju s palbociclib treba kombinirati s luteinizirajućeg hormona releasing hormon (lhrh) agonist.

Oronazol 20 mg/g šampon Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

oronazol 20 mg/g šampon

stada d.o.o., hercegovačka 14, zagreb, hrvatska - ketokonazol - šampon - 20 mg/g - urbroj: jedan gram šampona sadrži 20 mg ketokonazola

Afinitor Europska Unija - hrvatski - EMA (European Medicines Agency)

afinitor

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastična sredstva - hormon-receptor pozitivnim čest grudi cancerafinitor indiciran za liječenje hormon-receptor pozitivan, i her2/neu-negativan preliminarnim raka dojke, u kombinaciji s exemestane, u post-menopausal žene bez simptomatske brutalna patologije nakon recidiva ili progresije bolesti nakon non-steroidal i abs битор. Нейроэндокринные tumora gušterače originafinitor indiciran za liječenje operirati ili метастатической, dobro ili umjereno diferencirani нейроэндокринные tumora gušterače podrijetla u odraslih s прогрессирующим bolest. Нейроэндокринные tumora gastrointestinalnog trakta ili pluća originafinitor indiciran za liječenje operirati ili метастатической dobro diferenciranih (klase 1 ili klase 2) нефункционирующие нейроэндокринные tumora gastrointestinalnog ili plućne bolesti podrijetla u odraslih s прогрессирующим bolest. Почечно-stanični carcinomaafinitor indiciran za liječenje bolesnika s prevladava почечно-stanica karcinoma, bolesti koje развивало nakon obrade na vegf-таргетной terapija.

Yervoy Europska Unija - hrvatski - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - Ипилимумаб - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastična sredstva - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 i 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.