Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eli lilly nederland b.v. - dulaglutide - diabetes mellitus, tip 2 - drugs used in diabetes, blood glucose lowering drugs, excl. insulins - trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. għall-riżultati tal-istudju fir-rigward tal-kombinazzjonijiet, l-effetti fuq il-kontroll gliċemiku u episodji kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4. 4, 4. 5 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eli lilly nederland b.v. - olanzapine pamoate - skizofrenija - psikolettiċi - trattament ta 'manteniment ta' pazjenti adulti bi skiżofrenija stabbilizzati biżżejjed waqt kura akuta b'olanzapine orali.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

teva b.v. - topotecan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - aġenti antineoplastiċi - topotecan monotherapy is indicated for the treatment of: , patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;, patients with relapsed small cell lung cancer [sclc] for whom re-treatment with the first-line regimen is not considered appropriate. , topotecan flimkien ma ' cisplatin huwa indikat għall-pazjenti b'karċinoma taċ-ċerviċi rikorrenti wara radjuterapija u għall-pazjenti bil-marda fl-istadju ivb. pazjenti li qabel kellhom esponiment għal-cisplatin jinħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament bil-kombinazzjoni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - aġenti antineoplastiċi - rituzena huwa indikat fl-adulti għall-indikazzjonijiet li ġejjin:mhux ta 'hodgkin (nhl)rituzena huwa indikat għall-kura ta' pazjenti mhux trattati qabel ma l-istadju iii-iv limfoma follikulari flimkien mal-kimoterapija. rituzena monoterapija hija indikata għat-trattament ta 'pazjenti b'stadju iii-iv limfoma follikulari li huma kemo reżistenti jew li qegħdin fit-tieni jew aktar episodju ta' rkadar wara kimoterapija. rituzena huwa indikat għall-kura ta 'pazjenti bil-tixrid pożittiv cd20 taċ-ċelluli b kbar mhux ta' hodgkin il-limfoma f'kombinazzjoni ma ' chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) l-kimoterapija. lewkimja limfoċitika kronika (cll)rituzena flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja cll. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituzenaor pazjenti refrattarji għal preċedenti rituzena flimkien ma ' kimoterapija. granulomatosi b'polianġite u mikroskopika polyangiitisrituzena, flimkien ma 'glukokortikosterojdi, huwa indikat għall-induzzjoni ta' remissjoni f'pazjenti adulti b'mard sever, attiv granulomatosi b'polianġite (wegener) (fap) u polianġite mikroskopika (mpa).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, kobikistat, emtricitabine, tenofovir alafenamide - infezzjonijiet ta 'hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza huwa indikat għat-trattament tal-virus ta ' immunodefiċjenza umani tat-tip 1 (hiv‑1) infezzjoni fl-adulti u l-adolexxenti (età 12-il sena u aktar antiki mal-korp tal-mill-inqas 40 kg piż). genotypic testing should guide the use of symtuza.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - aġenti antineoplastiċi - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - aġenti antitrombotiċi - prasugrel mylan, ko-amministrat ma ' acetylsalicylic acid (asa), huwa indikat għall-prevenzjoni ta'avvenimenti aterotrombotiċi f'pazjenti adulti b'sindromu koronarju akut (i. anġina instabbli, mhux tas-segment st 'infart mijokardijaku b'elevazzjoni [ua/nstemi] jew elevazzjoni tas-segment st' infart mijokardijaku [stemi]) li għaddejjin minn primarju jew ittardjat ta ' intervent koronarju perkutaneju (pci).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine, lamivudine, tenofovir disoproxil fumarate - infezzjonijiet ta 'hiv - antivirali għat-trattament ta 'infezzjonijiet bl-hiv, kombinazzjonijiet - delstrigo huwa indikat għat-trattament ta 'adulti infettati bl-hiv-1 mingħajr passat jew fil-preżent evidenza ta' reżistenza għall-klassi nnrti, lamivudine, jew tenofovir. delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with hiv-1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - infezzjonijiet akkwistati mill-komunità - antibatteriċi għal użu sistemiku, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 u 5. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.