Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatonin - sleep inizjattiva u maintenance disorders - psikolettiċi - circadin huwa indikat bħala monoterapija għat-trattament għal żmien qasir ta 'nuqqas ta' rqad primarju kkaratterizzat minn kwalità fqira ta 'rqad f'pazjenti li għandhom 55 sena jew aktar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - immunosuppressanti selettivi - kolite colitisentyvio huwa indikat għall-kura ta ' pazjenti adulti b'attiva minn moderata sa gravi kolite bl-ulċeri li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew fattur tan-nekrożi tat-tumur alfa (tnfa) antagonist. crohn diseaseentyvio huwa indikat għall-kura ta 'pazjenti adulti b'attiva minn moderata sa gravi marda ta' crohn li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew fattur tan-nekrożi tat-tumur alfa (tnfa) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharma a/s - fentanyl citrate - pain; cancer - analġeżiċi - instanyl huwa indikat għall-immaniġġjar ta 'uġigħ qawwi f'adulti li diġà qed jirċievu terapija ta' manteniment ta 'opjojdi għal uġigħ kroniku tal-kanċer. l-uġigħ fil-qosor huwa aggravament tranżitorju ta 'uġigħ li jseħħ fuq sfond ta' uġigħ persistenti ikkontrollat ​​mod ieħor.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda france sas - mifamurtide - osteosarcoma - immunostimulanti, - mepact huwa indikat fit-tfal, adolexxenti u adulti żgħar għat-trattament ta 'osteosarcoma mhux metastatiku li jista' jiġi rkuprat ta 'grad għoli wara riżezzjoni kirurġika kompluta b'mod makroskopiku. jintuża flimkien ma 'kimoterapija ta' diversi aġenti wara l-operazzjoni. is-sigurtà u l-effikaċja ġew ivvalutati fi studji ta 'pazjenti minn sentejn sa 30 sena fid-dijanjożi inizjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - iperplażja prostatika - uroloġiċi - trattament tas-sinjali u sintomi ta 'iperplażja beninna tal-prostata (bph).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharma a/s - darvadstrocel - fir-rektum fistula - immunosoppressanti - alofisel huwa indikat għall-kura tal-kumpless perianal fistuli fil-pazjenti adulti bi mhux attivi/ħafif attiva luminal-marda ta ' crohn, meta fistuli wrew rispons inadegwat għal mill-inqas wieħed konvenzjonali jew terapija bijoloġiku. alofisel għandu jintuża wara l-ipproċessar tal-fistula.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - Ħnieżer - vaċċini - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. the use of qdenga should be in accordance with official recommendations.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatonin - sleep initiation and maintenance disorders; autistic disorder - psikolettiċi - slenyto huwa indikat għat-trattament ta 'nuqqas ta' rqad fit-tfal u l-adolexxenti ta ' minn 2-18-il bl-awtiżmu-ispettru disturb (petite) u / jew smith-magenis-sindromu, fejn l-irqad-iġjene miżuri ġew insuffiċjenti.