Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

immedica pharma ab - sodium phenylbutyrate - ornithine carbamoyltransferase deficiency disease; citrullinemia; carbamoyl-phosphate synthase i deficiency disease - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - ammonaps hu indikat bħala terapija aġġuntiva fit-kroniku tal-ġestjoni tal-urea disturbi fiċ-ċiklu, li jinvolvi defiċjenzi tal-carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. huwa indikat fil-pazjenti kollha b'neonatal-onset presentation (tlesti l-enżima n-nuqqasijiet li jidhru fl-ewwel 28 ġurnata tal-ħajja). huwa indikat ukoll f'pazjenti bil-marda li ħarġet tard(nuqqasijiet parzjali fl-enżimi, li jidhru wara l-ewwel xahar tal-ħajja) li għandhom storja ta ' enċefalopatija iperammonemika.

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)

biogen netherlands b.v. - nusinersen sodium - atrofija muskolari, spinali - drogi oħra tas-sistema nervuża - spinraza hija indikata għat-trattament ta '5q atrofija muskolari spinali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

clinigen healthcare b.v. - dexrazoxane hydrochloride - extravasazzjoni ta 'materjali dijanjostiċi u terapewtiċi - il-prodotti terapewtiċi l-oħra kollha - savene huwa indikat għat-trattament ta 'l-extravasazzjoni ta' anthracycline.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - patiromer sorbitex calcium - iperkalemija - - mediċini għal-kura tal-iperkalimja u ' l-iperphosphatemija - veltassa huwa indikat għall-kura ta 'iperkalimja fl-adulti.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - eviplera huwa indikat għall-kura ta ' adulti infettati bil-virus ta ' immunodefiċjenza umani tat-tip 1 (hiv-1) mingħajr mutazzjonijiet magħrufa assoċjati mal-reżistenza għall-klassi ta ' l-inibitur (nnrti) in-nuqqas ta ' nukleosidi rivers transcriptase, tenofovir jew emtricitabine, u mal-virali jillowdja ≤ 100,000 hiv-1 rna kopji/ml. bħal prodotti mediċinali antiretrovirali oħra, l-ittestjar tar-reżistenza ġenotipika u / jew id-dejta ta 'reżistenza storika għandhom jiggwidaw l-użu ta' eviplera.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd. - palonosetron hydrochloride - vomiting; cancer - anti-emetiċi u anti-nawżjanti, , serotonin (5ht3) antagonisti - aloxi hu indikat fl-adulti għall -: il-prevenzjoni ta ' dardir u rimettar assoċjati ma'kimoterapija tal-kanċer ferm emetoġenika,il-prevenzjoni ta'nawseja u rimettar assoċjati ma'kimoterapija tal-kanċer moderatament emetoġenika. aloxi hu indikat f'pazjenti pedjatriċi 1 xahar ta'l-età u akbar għal:prevenzjoni ta ' dardir u rimettar assoċjati ma'kimoterapija tal-kanċer ferm emetoġenika u għall-prevenzjoni ta'nawseja u rimettar assoċjati ma'kimoterapija tal-kanċer moderatament emetoġenika.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

baxter holding b.v. - doxorubicin hydrochloride - sarcoma, kaposi; multiple myeloma; ovarian neoplasms; breast neoplasms - aġenti antineoplastiċi - caelyx liposomali pegilat huwa indikat:bħala monoterapija għal pazjenti b'kanċer tas-sider metastatiku, fejn hemm żieda ta 'riskju kardijaċi;għall-kura avvanzata ta' l-ovarji f'nisa li jkunu fallew l-ewwel linja bbażata fuq il-platinu 'kors ta' kimoterapija;flimkien ma 'bortezomib għall-kura tal-mjeloma multipla progressiva f'pazjenti li rċevew mill-anqas terapija waħda qabel u li diġà għaddew jew li mhumiex tajbin għal trapjant tal-mudullun;għat-trattament tal-aids marbuta mal-sarkoma ta'kaposi (ks) f'pazjenti b'għadd ta' cd4 baxx (.