यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, tromboċitopenika, idjopatika - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 u 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 u 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - aġenti antineoplastiċi - bevacizumab flimkien ma 'kimoterapija bbażata fuq fluoropyrimidine huwa indikat għall-kura ta' pazjenti adulti b'karċinoma metastatika tal-kolon jew tar-rektum. bevacizumab f'kombinazzjoni ma 'paclitaxel, huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider. għal aktar informazzjoni kif tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2) status. bevacizumab f'kombinazzjoni ma 'capecitabine huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider li fihom it-trattament bil-kimoterapija oħra għażliet inklużi l-tassani jew antraċiklini ma jkunx ikkunsidrat xieraq. pazjenti li rċivew korsijiet li fihom taxxaane u anthracycline fl-istabbiliment awżiljarju fl-aħħar 12-il xahar għandhom jiġu esklużi mit-trattament b'avastin flimkien ma 'capecitabine. għal aktar informazzjoni dwar her2-istatus. bevacizumab, barra minn hekk 'kimoterapija bbażata fuq platinum, huwa ndikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. bevacizumab, f'kombinazzjoni ma 'erlotinib, huwa indikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti mhux squamous taċ-ċelluli mhux żgħar tal-pulmun il-kanċer mar-riċettur tal-fattur tat-tkabbir epidermali (egfr) mutazzjonijiet li jattivaw. bevacizumab f'kombinazzjoni ma 'interferon alfa-2a huwa indikat għall-ewwel linja tal-kura ta' pazjenti adulti b'avvanzat u/jew metastatiku taċ-ċelluli renali kanċer. bevacizumab, f'kombinazzjoni ma 'carboplatin u paclitaxel huwa ndikat għall-quddiem il-linja ta 'trattament ta' pazjenti adulti b'avvanzati (il-federazzjoni internazzjonali tal-mard tal-ġilda u l-ostetriċja (medjevali) stadji iii b, iii u iv) ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer. bevacizumab, f'kombinazzjoni ma 'carboplatin u gemcitabine, huwa indikat għall-kura ta' pazjenti adulti bil-ewwel rikorrenza tal-sensittiva għall-platinum ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan jew primarja peritoneali-kanċer li ma rċevew terapija minn qabel ma 'bevacizumab, jew l-oħra' impedituri vegf jew vegf–riċetturi fil-mira l-aġenti. bevacizumab f'kombinazzjoni ma 'paclitaxel, topotecan, jew pegylated liposomal doxorubicin huwa indikat għat-trattament ta' pazjenti adulti bil-platinu-reżistenti rikorrenti ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer li ma rċeviet l-ebda aktar minn żewġ qabel ma 'korsijiet ta' kimoterapija u li qatt ma kienu rċevew terapija minn qabel ma 'bevacizumab, jew l-oħra' impedituri vegf jew vegf–riċetturi fil-mira l-aġenti. bevacizumab, flimkien ma 'paclitaxel u cisplatin jew, alternattivament, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu l-platinum-terapija, huwa indikat għall-kura ta' pazjenti adulti b'persistenti, rikorrenti, jew karċinoma metastatika taċ-ċerviċi.

यूरोपीय संघ - माल्टीज़ - 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 - aġenti antineoplastiċi - 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. , l-effett ta 'glivec fuq l-eżitu ta' l-għadam-trapjant tal-mudullun għadu ma ġiex determinat. 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. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja;, il-kura ta'pazjenti adulti li ma jistax jitneħħa dermatofibrosarcoma protuberans (dfsp) u pazjenti adulti bil-rikorrenti u / jew metastatiku dfsp li mhumiex eliġibbli għall-kirurġija. , f'pazjenti adulti u pedjatriċi, l-effikaċja ta 'glivec hija bbażata fuq globali ematoloġiċi u ċitoġenetiċi-rati ta' rispons u sopravivenza mingħajr progressjoni f'cml, fuq ematoloġiċi u ċitoġenetiċi-rati ta 'rispons f'ph+ all, mds / mpd, fuq il-rati ta' rispons ematoloġiku f'hes / cel u dwar l-objettiv tal-rati ta ' rispons fil-pazjenti adulti li ma jistax jitneħħa u / jew metastiku-gist u dfsp u dwar ir-rikorrenza-sopravivenza mingħajr progressjoni fl-adjuvant gist. l-esperjenza bi glivec f'pazjenti b'mds / mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna (ara taqsima 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

यूरोपीय संघ - माल्टीज़ - 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 - aġenti antineoplastiċi - 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. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja. 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. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - sklerosi multipla - immunosoppressanti - trattament ta 'pazjenti adulti b'forom ta' sklerożi multipla (rms) li jirkadu b'mard attiv iddefinit minn karatteristiċi kliniċi jew ta 'immaġini. it-trattament ta 'pazjenti adulti b'kmieni sklerosi multipla progressiva primarja (ppms) fit-termini tal-mard tal-tul u l-livell tad-diżabilità, u bl-immaġni karatteristiċi ta' l-attività infjammatorja.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

mylan ireland limited - dimetil fumarate - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

zaklady farmafarmaceutyczne polpharma s.aceutyczne polpharma s.a. - dimetil fumarate - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - dimethyl fumarate polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

teva gmbh - dimetil fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - dimethyl fumarate teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimetil fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).