האיחוד האירופי - מלטית - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - newtropenja - immunostimulanti, - grastofil huwa indikat għall-tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati ma chemotherapy ċitotossiċi stabbiliti għall-malignancy (bl-eċċezzjoni tal-lewċemja myeloid kronika u myelodysplastic sindromi) u għat-tnaqqis fit-tul tal-neutropenia fil-pazjenti sottoposti għal terapija myeloablative segwit mill-mudullun trapjant meqjusa li huma f'riskju akbar ta ' neutropenia ħorox imtawla. is-sigurtà u l-effikaċja ta grastofil huma simili fl-adulti u t-tfal li qed jirċievu kimoterapija ċitotossika. grastofil huwa indikat għall-mobilizzazzjoni ta ' ċelluli proġenituri tad-demm (pbpcs). f'pazjenti, tfal jew adulti b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' ≤ 0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti fit-tul fit-amministrazzjoni tal-grastofil huwa indikat biex jiżdied l-għadd ta'newtrofili u biex inaqqas l-inċidenza u t-tul ta ' l-infezzjoni avvenimenti relatati mal-. grastofil huwa indikat għall-kura ta 'newtropenja persistenti (anc ta' inqas minn jew ugwali għal 1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

sandoz gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulanti, - tnaqqis fid-dewmien ta 'newtropenja u l-inċidenza ta' newtropenja bid-deni f'pazjenti kkurati b'kimoterapija ċitotossika stabbilita għal malinn (bl-eċċezzjoni ta 'lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat-tnaqqis fid-dewmien ta' newtropenja f'pazjenti li jkollhom terapija majeloablattiva segwita mill-għadam-trapjant tal-mudullun kkunsidrati li jkunu f'riskju akbar fit-tul ta ' newtropenja severa. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. il-mobilizzazzjoni tal-taċ-ċelluli proġenitriċi tad-demm periferali (pbpc). fit-tfal u fl-adulti bi ħsara severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' ≤0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti fit-tul fit-amministrazzjoni ta 'filgrastim hu indikat biex iżid l-għadd tan-newtrofili u biex inaqqas l-inċidenza u t-tul ta' l-infezzjoni avvenimenti relatati mal-. il-kura ta ' newtropenja persistenti (anc ≤ 1. 0 x 109/l) f'pazjenti b'infezzjoni avvanzata tal-hiv, sabiex jitnaqqas ir-riskju ta ' infezzjonijiet batterjali meta għażliet terapewtiċi oħrajn ma jkunux adattati.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - aġenti antineoplastiċi - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - aġenti antineoplastiċi - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

sandoz gmbh - epoetin alfa - anemia; kidney failure, chronic - preparazzjonijiet antianemiċi - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. l-istat kardjovaskulari pre-eżistenti ta ' l-anemija fil-bidu tal-kimoterapija).

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

gentium s.r.l. - defibrotide - mard epatiku-okklussiv tal-vini - aġenti antitrombotiċi - defitelio huwa indikat għall-kura ta ' severi epatiċi okklussivi veno marda (vod) magħrufa wkoll bħala sinusojdali eliminat syndrome (sos) f'terapija haematopoietic-ċelloli staminali trapjant (hsct). huwa indikat fl-adulti u fl-adoloxxenti, tfal u trabi ' l fuq minn 1 xahar ta'età.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

hexal ag - epoetin alfa - anemia; kidney failure, chronic; cancer - preparazzjonijiet antianemiċi - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. , it-trattament ta 'anemija u tnaqqis tal-ħtiġijiet ta' trasfużjoni f'pazjenti adulti li qed jirċievu kimoterapija għal tumuri solidi, limfoma malinn jew myeloma multipla, u f'riskju ta ' trasfużjoni kif evalwat mill-pazjent ġenerali tal-istatus (e. l-istat kardjovaskulari pre-eżistenti ta ' l-anemija fil-bidu tal-kimoterapija).

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - voriconazole - bacterial infections and mycoses; aspergillosis; candidiasis - antimikotiċi għal użu sistemiku - voriconazole huwa triazole bi spettru wiesa'li aġent antifungali u hija indikata fl-adulti u t-tfal b'età minn 2 snin u l-fuq kif ġej:trattament ta 'asperġillożi invażiva;it-trattament ta'candidaemia f'pazjenti mhux newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji candida reżistenti (inkluż c. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn scedosporium spp. u fusarium spp. voriconazole għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet. profilassi ta ' infezzjonijiet fungali invażivi f'riskju għoli alloġeneiċi trapjant ta'ċelloli staminali ematopojetiċi (hsct)riċevituri.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

pfizer europe ma eeig - voriconazole - candidiasis; mycoses; aspergillosis - antimikotiċi għal użu sistemiku - voriconazole, huwa triazole bi spettru wiesa'li aġent antifungali u hija indikata fl-adulti u t-tfal b'età minn 2 snin u l-fuq kif ġej:trattament ta 'asperġillożi invażiva;it-trattament tal fil-candidaemianon-pazjenti newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji candida reżistenti (inkluż c. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn scedosporium spp. u fusarium spp. vfend għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet. profilassi ta ' infezzjonijiet fungali invażivi f'riskju għoli alloġeneiċi trapjant ta'ċelloli staminali ematopojetiċi (hsct) riċevituri.