Kesatuan Eropah - Romania - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - agenți antineoplazici - glivec 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-pdgfra rearrangement. , efectul de glivec cu privire la rezultatul de măduvă osoasă transplant nu a fost determinată. glivec is indicated for: , 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. pacienții care au un risc scăzut sau foarte scăzut de recidivă nu trebuie să primească tratament adjuvant;, tratamentul pacienților adulți cu inoperabil dermatofibrosarcomul protuberans (pdfs) și la pacienții adulți cu recidivante și / sau metastatice pdfs care nu sunt eligibile pentru o intervenție chirurgicală. , la pacienții adulți și copii, eficacitatea de glivec este bazat pe ansamblu de răspuns hematologic și citogenetic prețurile și supraviețuirea fără progresie în lmc, pe de răspuns hematologic și citogenetic rate în lla ph+, mds / mpd, pe ratele de răspuns hematologice în she / lec și pe criterii obiective, ratele de răspuns la pacienții adulți cu inoperabile și / sau metastatice gist și pdfs și pe repetarea de supraviețuire fără adjuvant în gist. experiența cu glivec la pacienții cu mds / mpd asociate cu genei fcdp-re-aranjamente este foarte limitată (vezi secțiunea 5. cu excepția nou diagnosticate în faza cronică a lgc, nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. vezi secțiunile 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Kesatuan Eropah - Romania - 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. cu excepția nou diagnosticate în faza cronică a lgc, nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli. .

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

cangene europe limited - imunoglobulină umană împotriva hepatitei b - immunization, passive; hepatitis b - imunoglobuline specifice - imunoprofilaxia hepatitei b - În caz de expunere accidentală în non-imunizați subiecți (inclusiv persoanele a căror vaccinare isincomplete sau statut necunoscut). - in la cei hemodializați, până vaccinarea a devenit eficient. - la nou-nascuti de un purtător virusul hepatitei b-mama. - la subiecții care nu prezintă un răspuns imunitar (nu măsurabile hepatita b anticorpi) după vaccinare și pentru care o continuă prevenirea este necesară din cauza riscului permanent de a fi infectat cu hepatita b. ar trebui să fie, de asemenea, dat la alte ghidurile oficiale privind utilizarea adecvată a omului imunoglobulină împotriva hepatitei b pentru administrare intramusculară.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabetul zaharat, tip 2 - medicamente utilizate în diabet - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 și 5.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - medicamente utilizate în diabet - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 și 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

aventis pharma s.a. - telitromicină - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - antibacteriene pentru uz sistemic, - atunci când se prescrie ketek, trebuie luate în considerare orientările oficiale privind utilizarea adecvată a agenților antibacterieni și prevalența locală a rezistenței. ketek este indicat pentru tratamentul următoarelor infecții:la pacienți cu vârsta de 18 ani și oldercommunity pneumonie dobândită, ușoare sau moderate. atunci când se tratează infecții cauzate de cunoscute sau suspectate beta-lactamice și / sau macrolide-tulpini rezistente (în conformitate cu istorie de pacienți sau naționale și / sau regionale de rezistență date) obiectul antibacterian cu spectru de telitromicină:exacerbarea acută a bronșitei cronice;sinuzita acuta;la pacienți cu vârsta de 12 ani și oldertonsillitis / faringitei cauzate de streptococcus pyogenes, ca o alternativă la antibiotice beta-lactamice nu sunt adecvate în țările / regiunile cu o prevalență semnificativă de macrolide-rezistent la s. pyogenes, când mediată de ermtr sau mefa.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil clorhidrat de - neoplasme colorectale - agenți antineoplazici - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

astellas pharma europe b.v. - tacrolimus - respingerea grefei - imunosupresoare - profilaxia respingerii transplantului la adulți și adolescenți adulți, pediatrici, rinichi, ficat sau inimă. tratamentul rejetului de alogrefă rezistent la tratamentul cu alte medicamente imunosupresoare la pacienții adulți și copii.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

mediwound germany gmbh - proteolytic enzymes enriched in bromelain - debridare - preparate pentru tratarea rănilor și ulcerelor - nexobrid este indicat pentru îndepărtarea escarului la adulți cu arsuri termice parțiale și cu grosime totală.