Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicin hydrochloride - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - aġenti antineoplastiċi - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eli lilly nederland b.v. - glucagon - diabetes mellitus - - frixa l-ormoni, glycogenolytic-ormoni - baqsimi huwa indikat għall-kura ta 'ipogliċemija severa fl-adulti, l-adoloxxenti u tfal ta' 4 snin u aktar bid-dijabete mellitus.

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)

intervet international bv - babesia canis, inactivated, babesia rossi, inactivated - immunoloġiċi għall-canidae - klieb - għal immunizzazzjoni attiva ta 'klieb ta' sitt xhur jew aktar kontra babesia canis biex titnaqqas is-severità tas-sinjali kliniċi assoċjati ma 'babesiosis akuta (b. canis) u anemija kif imkejla bil-volum taċ-ċelluli ppakkjati. il-bidu tal-immunità: tliet ġimgħat wara l-kors bażiku tat-tilqim. tul ta 'żmien tal-immunità: sitt xhur wara l-aħħar vaċċinazzjoni (mill-ġdid).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alexion europe sas - eculizumab - emoglobinurja, paroxysmal - immunosoppressanti - soliris huwa indikat fl-adulti u t-tfal għall-kura ta': emoglobinurja notturnali parossimali (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. atipiċi sindromu uremiku emolitiku (ahus). soliris huwa indikat fl-adulti għall-kura ta': ġeneralizzati refrattarji myasthenia gravis (gmg) f'pazjenti li huma kontra l-acetylcholine-riċettur (achr) antikorpi pożittivi (ara sezzjoni 5. neuromyelitis maws ottiku għall-logħob tal-ispettru disturb (nmosd) f'pazjenti li huma kontra l-aquaporin-4 (aqp4) antikorpi pożittivi bl-isklerożi multipla reċidiva-kors tal-marda.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alnylam netherlands b.v. - patisiran sodium - amilojdożi, familjali - drogi oħra tas-sistema nervuża - onpattro huwa indikat għall-kura ta ' transthyretin medjat amilojdożi (hattr amilojdożi) f'pazjenti adulti bil-istadju ta'l-1 jew l-istadju 2 polinewropatija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

intervet international bv - vaċċin tal-vajrus tal-bluetongue, serotip 8 (mhux attivat) - vaċċini virali inattivati, virus tal-bluetongue, nagĦaĠ - sheep; cattle - cattle to stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia sheep to stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia,.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zoetis belgium sa - inactivated bluetongue virus, serotype 1, strain btv-1/alg2006/01, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02 - bluetongue virus, sheep, inactivated viral vaccines - nagħaġ - immunizzazzjoni attiva tan-nagħaġ minn 1. 5 xhur għall-prevenzjoni tal-viremija kkawżata mill-virus tal-bluetongue, is-serotipi 1 u 8. il-bidu tal-immunità: 21 jum wara t-tlestija tal-iskema ta 'tilqim primarju. tul ta 'żmien tal-immunità: 12-il xahar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biofrontera bioscience gmbh - idroklorur ta 'l-aċidu 5-aminolevuliniku - keratosis, actinic; carcinoma, basal cell - aġenti antineoplastiċi - it-trattament ta'keratosi aktinika ta ' severita ħafifa għal moderata fuq il-wiċċ u l-qorriegħa (olsen grad 1-2; ara t-taqsima 5. 1) u tal-qasam cancerization fl-adulti. it-trattament tal-superfiċjali u/jew nodular karċinoma taċ-ċellola bażali mhux tajbin għall-kura kirurġika minħabba possibbli relatati mal-kura-morbidità u/jew foqra kosmetiċi-eżitu fl-adulti.