Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanoma - aġenti antineoplastiċi - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 u 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. taċ-ċelluli mhux żgħar tal-pulmun (nsclc)trametinib flimkien ma dabrafenib huwa indikat għall-kura ta ' pazjenti adulti b'avvanzata taċ-ċelluli mhux żgħar tal-pulmun il-kanċer ma braf v600.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanoma - aġenti antineoplastiċi - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 u 5. kura awżiljarja tal-melanomadabrafenib flimkien ma trametinib huwa indikat għall-kura awżiljarja ta ' pazjenti adulti b'fażi iii melanoma bil-braf v600, wara li jitlesta r-risezzjoni. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pierre fabre medicament - busulfan - trapjant ta 'ċelloli staminali ematopojetiċi - aġenti antineoplastiċi - busilvex segwit minn cyclophosphamide (bucy2) huwa indikat bħala kondizzjonament trattament qabel haematopoietic konvenzjonali trapjant ta ' proġenitur taċ-ċelloli (hpct) fil-pazjenti adulti meta l-għaqda hija kkunsidrata l-aħjar għażla disponibbli. il-busilvex li ġejjin fludarabine (fb) hu indikat bħala trattament kondizzjonarju t-trapjant taċ-ċelluli ematopojetiċi proġenitriċi (hpct) f'pazjenti adulti li huma kandidati għall-imnaqqas-intensità tal-kondizzjonament (ric) reġimen. busilvex il-ċiklofosfamid (regimen bucy4) jew melfalan (bumel) hu indikat bħala trattament kondizzjonarju konvenzjonali taċ-ċelluli ematopojetiċi tat-trapjant fil-pazjenti pedjatriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - busulfan - trapjant ta 'ċelloli staminali ematopojetiċi - alkyl sulfonates - busulfan fresenius kabi warajh cyclophosphamide (bucy2) huwa indikat bħala kondizzjonament trattament qabel haematopoietic konvenzjonali trapjant ta ' proġenitur taċ-ċelloli (hpct) fil-pazjenti adulti meta l-għaqda hija kkunsidrata l-aħjar għażla disponibbli. busulfan fresenius kabi-ċiklofosfamid (regimen bucy4) jew melfalan (bumel) hu indikat bħala trattament kondizzjonarju konvenzjonali taċ-ċelluli ematopojetiċi tat-trapjant fil-pazjenti pedjatriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - aġenti antineoplastiċi oħra - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drogi għat-trattament ta 'mard tal-għadam - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. trattament ta ' osteoporożi assoċjat ma sistemiku fit-tul terapija bi glukokortikojdi fil-nisa wara l-menopawża u f'irġiel f'riskju akbar ta'ksur. it-trattament tal-marda ta'paget ta ' l-għadam.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - elotuzumab - majloma multipla - aġenti antineoplastiċi - empliciti huwa indikat, flimkien ma 'lenalidomide u dexamethasone għall-kura ta' majeloma multipla f'pazjenti adulti li jkunu rċevew mill-anqas terapija waħda qabel (ara sezzjonijiet 4. 2 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

dendreon uk ltd - awtologi periferali-ċelluli tad-demm lewkoċciti mononukleari inklużi minimu ta ' 50 miljun cd54 + għaċ-ċelloli awtoloġiċi attivat b'fattur fosfataŻi aċidu prostatic granulocyte-macrophage-istimulazzjoni tal-kolonja - neoplasmi prostatiċi - immunostimulanti oħrajn - provenge huwa indikat għat-trattament ta 'kanċer tal-prostata mhux sintomatiku sintomatiku jew sintomatiku metastatiku (mhux vixxerali) f'adulti maskili li fihom il-kemjoterapija għadha mhix indikata klinikament.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

teva b.v. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drogi għat-trattament ta 'mard tal-għadam - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. it-trattament tal-marda ta'paget ta ' l-għadam fl-adulti.