Euroopa Liit - malta - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - toxoid tad-difterite, toxoid tat-tetnu, ta ' bordetella pertussis, l-epatite b ippurifikat (rdna), haemophilus influenzae tat-tip b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; diphtheria - vaċċini - quintanrix huwa indikat għall-immunisation primarji tat-trabi (matul l-ewwel sena tal-ħajja) kontra diphtheria, tetanus, pertussis, epatite b u invażivi marda kkawżata mill-influwenza Ħemofillika tip b u għall-booster immunisation ta ' tfal matul il- it-tieni sena tal-ħajja. l-użu ta 'quintanrix għandu jiġi determinat fuq il-bażi ta' rakkomandazzjonijiet uffiċjali.

Euroopa Liit - malta - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Euroopa Liit - malta - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - aġenti antineoplastiċi - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris huwa indikat għall-kura ta 'pazjenti adulti b'all rikadut jew refrattarju cd30+ ta' hodgkin il-limfoma (hl):wara asct, orfollowing mill-inqas żewġ terapiji ta 'qabel meta asct jew multi-aġent tal-kimoterapija mhux għażla ta' trattament. sistemiċi astroċitoma l-kbira taċ-ċelluli lymphomaadcetris f'kumbinazzjoni ma ' cyclophosphamide, doxorubicin u prednisone (chp) huwa indikat għall-pazjenti adulti li ma ġietx ikkurata qabel sistemika astroċitoma l-kbira taċ-ċelluli tal-limfoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Euroopa Liit - malta - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - lewkimja, linfokitika, kronika, b-Ċellula - aġenti antineoplastiċi - mabcampath huwa indikat għall-kura ta 'pazjenti b'lewkimja limfoċitika kronika taċ-Ċellula b (bcll) li għalihom il-kemjoterapija kombinata ta' fludarabine mhijiex xierqa.

Euroopa Liit - malta - EMA (European Medicines Agency)

bayer ag  - octocog alfa - hemofilja a - sustanzi kontra l-emorraġija - trattament u profilassi ta 'fsada f'pazjenti b'emofilja a (nuqqas konġenitali ta' fattur viii). din il-preparazzjoni ma fihiex il-fattur von willebrand u għalhekk mhux indikat fil-von willebrand-marda tal -.

Euroopa Liit - malta - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - vaċċini - immunizzazzjoni attiva kontra mard invażiv u otite medja akuta kkawżata minn streptococcus pneumoniae fi trabi u tfal minn sitt ġimgħat sa ħames snin. ara t-taqsimiet 4. 4 u 5. 1 fl-informazzjoni dwar il-prodott għal informazzjoni dwar il-protezzjoni kontra serotipi pnewmokokkali speċifiċi. l-użu ta synflorix għandu jiġi determinat fuq il-bażi ta 'rakkomandazzjonijiet uffiċjali filwaqt li jitqiesu l-impatt ta' mard invażiv fi gruppi differenti ta ' età, kif ukoll il-varjabilità tal-epidemjoloġija tas-serotip f'żoni ġeografiċi differenti.

Euroopa Liit - malta - EMA (European Medicines Agency)

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.

Euroopa Liit - malta - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - antibatteriċi għal użu sistemiku, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Euroopa Liit - malta - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - aġenti antineoplastiċi - l-ormon tat-riċettur pożittiva tas-sider avvanzat cancerafinitor huwa indikat għall-kura ta 'l-ormon tat-riċettur-pożittivi, her2/neu negattivi għall-kanċer tas-sider avvanzat, f'kombinazzjoni ma exemestane, fil-nisa wara l-menopawsa mingħajr sintomatika vixxerali-marda wara l-rikorrenza jew l-progressjoni wara mediċini mhux sterojdi ta' inibitur aromatase. newroendokrinika tumuri tal-frixa originafinitor huwa indikat għall-kura ta li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza, sew jew moderatament differenzjati newroendokrinika tumuri tal-frixa-oriġini fl-adulti bil-marda progressiva. newroendokrinika tumuri tal-gastro-intestinali jew tal-pulmun originafinitor huwa indikat għall-kura ta li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza, differenzjat tajjeb (grad 1 jew ta ' grad 2) mhux funzjonali newroendokrinika tumuri tal-gastro-intestinali jew tal-pulmun-oriġini fl-adulti bil-marda progressiva. renali taċ-ċelluli carcinomaafinitor huwa indikat għall-kura ta ' pazjenti b'indeboliment avanzat tal-karċinoma taċ-ċellola, li l-marda tagħhom mexa fuq jew wara l-kura bil-vegf-terapija fil-mira.

Euroopa Liit - malta - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirine hydrochloride - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - edurant, f ' għaqda mal-oħrajn prodotti mediċinali antiretroviral, huwa indikat għall-trattament tal-virus ta ' immunodefiċjenza umani tat-tip 1 (hiv‑1) infezzjoni fil-pazjenti treatment‑naïve antiretroviral 12-il sena ta ' l-età u l-aktar antiki mal-≤ tagħbija virali 100,000 hiv‑1 rna kopji/ml. bħala ma ' prodotti mediċinali antiretrovirali oħra, l-ittestjar tar-reżistenza ġenotipika għandhom jiggwidaw l-użu tal-edurant.