Evropská unie - maltština - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - awtologi taċ-ċelluli cd34+ arrikkit-popolazzjoni li fiha l-trapjant ta ' ċelloli staminali transduced mal-lentiglobin bb305 lentiviral vector kodifikazzjoni il-beta-a-t87q-emoglobina ġene - beta-talassimja - other hematological agents - zynteglo huwa indikat għall-kura tal-pazjenti ta'12-il sena u akbar bi dipendenti mit-trasfużjoni β-talessimja (tdt) li ma jkollhomx β0/β0-ġenotip, li għalihom il-ċelluli staminali ematopojetiċi (hsc) trapjant huwa xieraq iżda tal-lewkoċiti tal-bniedem l-antiġen (hla) mqabbla relatati hsc tad-donaturi mhux disponibbli.

Evropská unie - maltština - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - majloma multipla - aġenti antineoplastiċi - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.

Evropská unie - maltština - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea. sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Evropská unie - maltština - EMA (European Medicines Agency)

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.

Evropská unie - maltština - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - epatite Ċ, kronika - antivirali għal użu sistemiku - ribavirin mylan huwa indikat għall-kura ta ' kronika epatite c u għandhom jintużaw biss bħala parti minn a dożaġġ tal-kombinazzjoni b ' interferon alfa-2b (adulti, tfal (tliet snin fl-età u l-eqdem) u l-adolexxenti). monoterapija b'ribavirin m'għandhiex tintuża. hemm l-ebda sigurtà jew effikaċja ta ' informazzjoni dwar l-użu ta ' ribavirin ma ' forom oħra ta ' interferon (i. mhux alfa-2b). jekk jogħġbok irreferi wkoll għall-interferon alfa-2b sommarju tal-karatteristiċi tal-prodott (spc) għall-informazzjoni dwar kif ikun preskritt dak il-prodott partikulari. naïve patientsadult patientsribavirin mylan huwa indikat, f'kombinazzjoni ma 'interferon alfa-2b, għall-kura ta' pazjenti adulti bil-tipi kollha ta 'epatite Ċ kronika ħlief-ġenotip 1, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal-fwied, b'livelli għoljin ta' alanine aminotransferase (alt), li huma pożittivi għall-serum ta ' l-epatite c-virus (hcv) rna. it-tfal u l-adolescentsribavirin mylan huwa indikat, f'kors ta 'kombinazzjoni ma' interferon alfa-2b, għall-kura ta 'tfal u adolexxenti minn tliet snin' il fuq, li għandhom it-tipi kollha ta ' epatite Ċ kronika ħlief-ġenotip 1, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal-fwied, u li huma pożittivi għall-hcv-rna. meta tiddeċiedi li ma li tipposponi it-trattament sakemm il-ħajja adulta, huwa importanti li wieħed jikkunsidra li l-terapija kombinata indotta-inibizzjoni tat-tkabbir. l-riversibbiltà ta ' inibizzjoni tat-tkabbir huwa inċert. id-deċiżjoni li l-kura għandha tittieħed fuq bażi ta'każ b'każ bażi (ara sezzjoni 4. qabel il-kura tal-insuffiċjenza tal-patientsadult patientsribavirin mylan huwa indikat, f'kombinazzjoni ma 'interferon alfa-2b, għall-kura ta' pazjenti adulti b'epatite c kronika li qabel kienu wrew rispons (bin-normalizzazzjoni ta 'alt fi tmiem il-kura) għal monoterapija ta' interferon alfa, iżda li wara rkadew.

Evropská unie - maltština - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumur stromali gastrointestinali - aġenti antineoplastiċi - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Evropská unie - maltština - EMA (European Medicines Agency)

biogen netherlands b.v.  - fampridine - sklerosi multipla - drogi oħra tas-sistema nervuża - fampyra huwa indikat għat-titjib tal-mixi f'pazjenti adulti bi sklerożi multipla b'diżabilità fil-mixi (skala ta 'status ta' diżabilità espandut 4-7).

Evropská unie - maltština - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - majjali - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Evropská unie - maltština - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - immunosoppressanti - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Evropská unie - maltština - EMA (European Medicines Agency)

biogen netherlands b.v.  - interferon beta-1a - sklerosi multipla - immunostimulanti, - avonex hu indikat għall-kura ta': pazjenti djanjostikati bl-isklerożi multipla reċidiva-isklerożi multipla (ms). fi provi kliniċi, dan ġie karaterizzat jew aktar akuta tal-aggravar tal-attakki (rikaduti) fit-tliet snin preċedenti mingħajr evidenza ta kontinwu progressjoni bejn l-attakki reċidivi; avonex inaqqas il-progressjoni tad-diżabilità u jnaqqas il-frekwenza tal-attakki reċidivi;pazjenti b'avveniment wieħed demyelinating bi proċess infjammatorju attiv, jekk ikun sever biżżejjed li jkun jeħtieġ il-kura b'kortikosterojdi ġol-vina, jekk dijanjosi alternattivi kienu esklużi, u jekk kien stabbilit li huma f'riskju għoli li jiżviluppaw ms klinikament definita. avonex għandu jitwaqqaf f'pazjenti li jiżviluppaw ms progressiva.