الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

novo nordisk a/s - insulin aspart - diabetes mellitus - drugs used in diabetes, insulins and analogues for injection, fast-acting - trattament tad-dijabete mellitus f'adulti, adolexxenti u tfal ta 'sena u aktar.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:it 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. it 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. it 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. it 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.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - nilemdo huwa indikat fl-adulti b'iperkolesterolemija primarja (eterozigote familjali u mhux familjali) jew dislipidemija mħallta, bħala żieda mad-dieta:f'kombinazzjoni ma 'statin jew statin oħra li jbaxxu l-lipidi terapiji fil-pazjenti li ma jistgħux jilħqu l-ldl-c-għanijiet mal-doża massima ttollerata ta' statin (ara sezzjonijiet 4. 2, 4. 3, u 4. 4), jew waħdu jew flimkien ma ' oħrajn li jbaxxu l-lipidi terapiji f'pazjenti li huma statin intolleranti għal, jew li għalihom il-statin huwa kontra-indikat.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid, ezetimibe - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - nustendi huwa indikat fl-adulti b'iperkolesterolemija primarja (eterozigote familjali u mhux familjali) jew dislipidemija mħallta, bħala żieda mad-dieta:f'kombinazzjoni ma 'statin fil-pazjenti li ma jistgħux jilħqu l-ldl-c-għanijiet mal-doża massima ttollerata ta' statin minbarra l-ezetimibealone f'pazjenti li huma statin jew intolleranti għal imatinib jew li għalihom statin huwa kontra-indikat, u ma jkunux jistgħu jilħqu livell ta ' ldl-c-għanijiet mal-ezetimibe waħdu,fil-pazjenti li diġà qegħdin jiġu kkurati b'kumbinazzjoni ta bempedoic acid u ezetimibe bħala pilloli separati bi jew mingħajr statin.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - immunosoppressanti - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 u 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 u 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - antithrombin alfa - defiċjenza ta 'antithrombin iii - aġenti antitrombotiċi - atryn huwa indikat għall-profilassi ta 'tromboemboliżmu fil-vini fil-kirurġija ta' pazjenti b'defiċjenza konġenitali ta 'antithrombin. atryn normalment jingħata flimkien ma 'eparina jew eparina b'piż molekulari baxx.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

gedeon richter plc. - norelgestromin, ethinyl estradiol - kontraċezzjoni - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - kontraċezzjoni femminili. evra huwa maħsub għal nisa f'età fertili. is-sigurtà u l-effikaċja tagħha ġiet stabbilita fin-nisa ta ' bejn it-18 u l-45 sena.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - papillomavirus uman tip 6 l1 proteina, tal-papillomavirus uman tip 11 l1 proteina, tal-papillomavirus uman tip 16 l1 proteina, tal-papillomavirus uman tip 18 l1 proteina - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vaċċini - gardasil huwa vaċċin għall-użu mill-età ta'9 snin għall-prevenzjoni ta': leżjonijiet ġenitali premalinni (ċervikali, tal-vulva u vaġinali), premalignant leżjonijiet anali, 'kanċers ċervikali u kanċer anali każwalment relatat ċerti onkoġeniċi-papillomavirus uman (hpv) tat-tipi;felul ġenitali (kondiloma acuminata) każwalment relatat speċifiċi tipi ta' hpv. ara t-taqsimiet 4. 4 u 5. 1 għal informazzjoni importanti dwar id-dejta li tappoġġja din l-indikazzjoni. l-użu ta ' gardasil għandu jkun skond ir-rakkomandazzjonijiet uffiċjali.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

cangene europe limited - immunoglobulina tal-epatite b umana - immunization, passive; hepatitis b - immunoglobulini speċifiċi - immunoprophylaxis ta 'l-epatite b fil - każ ta' espożizzjoni aċċidentali mhux pazjenti immunizzati (inklużi l-persuni li t-tilqima isincomplete jew status mhux magħruf). - fil-pazjenti fuq emodijalisi, sakemm it-tilqima għandha ssir effettiva. - fil-twelid tal-virus epatite b trasportatur ta'l-omm. - f'pazjenti li ma jurux rispons immuni (l-ebda li jistgħu jitkejlu l-epatite b ' antikorpi) wara t-tilqim u li għalihom kontinwu il-prevenzjoni hija meħtieġa minħabba l-kontinwu riskju li jiġu infettati bl-epatite b. konsiderazzjoni għandha tingħata wkoll għall-oħra, il-gwida uffiċjali fuq l-użu xieraq tal-bniedem ta 'l-epatite b' immunoglobulina għall-użu għal ġol-muskoli.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

merial - fipronil, amitraz, (s)-methoprene - ektoparasitaċidali għall-użu topiku, inklużi. insettiċidi - klieb - it-trattament u l-prevenzjoni ta ' infestazzjonijiet fil-klieb bil-qurdien (ixodes ricinus, dermacentor reticulatus, rhipicephalus sanguineus, ixodes scapularis, dermacentor variabilis, haemaphysalis elliptica, haemaphysalis longicornis, amblyomma americanum u amblyomma maculatum) u l-briegħed (ctenocephalides felis u ctenocephalides canis). trattament ta 'infestazzjonijiet mill-qamel (trichodectes canis). prevenzjoni tal-kontaminazzjoni tal-briegħed ambjentali billi jinibixxi l-iżvilupp tal-istadji immaturi kollha tal-briegħed. il-prodott jista 'jintuża bħala parti minn strateġija ta' trattament għall-kontroll tad-dermatite tal-allerġija tal-briegħed. eliminazzjoni ta 'briegħed u qurdien fi żmien 24 siegħa. trattament wieħed jipprevjeni aktar infestazzjonijiet għal ħames ġimgħat mill-qurdien u sa ħames ġimgħat minn briegħed. il-kura indirettament inaqqas ir-riskju ta 'trasmissjoni tal-qurdien li jinġarr-mard (klieb-babisjosi, monocytic ehrlichiosis, granulocytic anaplasmosis u borreliosis) minn qurdien infettati għal erba' ġimgħat.