Palladia Unjoni Ewropea - Malti - EMA (European Medicines Agency)

palladia

zoetis belgium sa - toceranib - aġenti antineoplastiċi - klieb - it-trattament ta mhux resectable patnaik grad-ii (intermedju-grad) jew iii (grad għoli), l-rikorrenti, tal-ġilda mast-tumuri taċ-ċelluli fil-klieb.

Darzalex Unjoni Ewropea - Malti - EMA (European Medicines Agency)

darzalex

janssen-cilag international n.v. - daratumumab - majloma multipla - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. f'kombinazzjoni ma 'bortezomib, thalidomide u dexamethasone għat-trattament ta' pazjenti adulti li jkunu għadhom kif ġew dijanjostikati mjeloma multipla li huma eliġibbli għall-awtologi-trapjant ta'ċelloli staminali. f'kombinazzjoni ma ' lenalidomide u dexamethasone, jew bortezomib u dexamethasone, għat-trattament ta'pazjenti adulti b'mjeloma multipla li rċievew mill-inqas terapija waħda qabel. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. bħala monoterapija għall-kura ta ' pazjenti adulti b'all rikadut u refrattarji mjeloma multipla, li qabel it-terapija inkluż inibitur tal-proteasome u immunomodulatorji-aġent u li jkunu wrew-progressjoni tal-marda fl-aħħar terapija. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Pregabalin Accord Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pregabalin accord

accord healthcare s.l.u. - pregabalin - anxiety disorders; epilepsy - anti-epilettiċi, - epilepsypregabalin qbil huwa indikat bħala terapija aġġuntiva f'persuni adulti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja. ta'ansjetà ġeneralizzata disorderpregabalin qbil huwa indikat għall-kura ta 'disturb ta' ansjetà Ġeneralizzata (gad-generalised anxiety disorder) f'persuni adulti.

Tasmar Unjoni Ewropea - Malti - EMA (European Medicines Agency)

tasmar

viatris healthcare limited - tolcapone - marda ta 'parkinson - kontra l-marda ta ' parkinson id-drogi, aġenti dopaminerġiċi oħra - tasmar hija indikata fil kombinazzjoni ma ' ticlopidine hydrochloride / benserazide jew ticlopidine hydrochloride / carbidopa għall-użu fil-pazjenti ma ticlopidine hydrochloride-responsivi idiopathic parkinson's marda u oxxillazzjonijiet vetturi bil-mutur, li naqas milli jirrispondi għal jew huma intolerant ta ' xulxin inibituri ta ' catechol-o-methyltransferase (comt). minħabba r-riskju ta potenzjalment fatali, ħsara fil-fwied akut, tasmar ma għandhomx jiġu kkunsidrati bħala l-ewwel linja ta 'trattament miżjud ma' levodopa / benserazide jew levodopa / carbidopa. peress li tasmar għandu jiġi użat biss flimkien ma 'levodopa / benserazide u b'levodopa / carbidopa, l-tagħrif preskritt individwalment għal dawn l-sustanzi ta' levodopa hija applikabbli għall-użu tagħhom flimkien ma ' tasmar.

Fabrazyme Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fabrazyme

sanofi b.v. - agalsidase beta - marda ta 'fabry - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - fabrazyme huwa indikat għal terapija ta 'sostituzzjoni ta' enzimi fit-tul f'pazjenti b'dijanjosi kkonfermata ta 'marda ta' fabry (defiċjenza ta 'α-galaktosidase-a).

Carvykti Unjoni Ewropea - Malti - EMA (European Medicines Agency)

carvykti

janssen-cilag international nv - ciltacabtagene autoleucel - majloma multipla - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Nyxthracis (previously Obiltoxaximab SFL) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

nyxthracis (previously obiltoxaximab sfl)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - sera immuni u immunoglobulini, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Elzonris Unjoni Ewropea - Malti - EMA (European Medicines Agency)

elzonris

stemline therapeutics b.v. - tagraxofusp - lymphoma - aġenti antineoplastiċi - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

Adcirca (previously Tadalafil Lilly) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

adcirca (previously tadalafil lilly)

eli lilly nederland b.v. - tadalafil - pressjoni għolja, pulmonari - uroloġiċi - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. l-effikaċja ntweriet f'aph idjopatika (ipah) u f'pah relatata mal-marda vaskulari tal-kollaġen. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Bekemv Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bekemv

amgen technology (ireland) uc - eculizumab - emoglobinurja, paroxysmal - immunosoppressanti - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). l-evidenza ta 'benefiċċju kliniku hija murija f'pazjenti b'emodijalisi ma' sintomi kliniċi(i) indikattiv ta'l-attività għolja tal-marda, irrispettivament mill-trasfużjoni-istorja (ara sezzjoni 5.