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)

pfizer europe ma eeig - zoledronic acid monohydrate - iperkalċemija - drogi għat-trattament ta 'mard tal-għadam - 4 mg / 5 ml u 4 mg / 100 ml:il-prevenzjoni ta ' episodji relatati ma (ksur patoloġiku, kompressjoni tas-sinsla, radjazzjoni jew kirurġija fl-għadam, jew l-iperkalċemja kkawżata minn tumur) f'pazjenti adulti b'kanċer avvanzat li jinvolvi l-għadam. it-trattament ta ' pazjenti adulti b'iperkalċemja kkawżata minn tumur (tih). 5 mg / 100 ml: - trattament tal-osteoporożi:fl-nisa wara l-menopawsa;fl-irġiel;f'riskju akbar ta ' ksur, inklużi dawk bi trawma-ksur fil-ġenbejn. trattament ta ' osteoporożi assoċjat ma sistemiku fit-tul terapija bi glukokortikojdi:fl-nisa wara l-menopawsa;fl-irġiel;f'riskju miżjud ta'ksur. it-trattament tal-marda ta'paget ta ' l-għadam fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - zoledronic acid monohydrate - fractures, bone; cancer - drogi għat-trattament ta 'mard tal-għadam - prevenzjoni ta 'avvenimenti relatati mal-iskeletru (fratturi patoloġiċi, kompressjoni spinali, radjazzjoni jew kirurġija għal għadam, jew iperkalċemija kkawżata minn tumur) f'pazjenti adulti b'tumuri avvanzati malinni li jinvolvu l-għadam. it-trattament ta ' pazjenti adulti b'iperkalċemja kkawżata minn tumur (tih).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

actavis group ptc ehf   - zoledronic acid monohydrate - fratturi, għadam - drogi għat-trattament ta 'mard tal-għadam - prevenzjoni ta ' l-iskeletru relatati mal-avvenimenti (fratturi patoloġiċi, kompressjoni sinsla, radjazzjoni jew kirurġija mal-għadam, jew tumur indott hypercalcaemia) fil-pazjenti adulti ma malignancies avvanzati li jinvolvu l-għadam. it-trattament ta ' pazjenti adulti b'iperkalċemja kkawżata minn tumur.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, rilpivirina hydrochloride, tenofovir alafenamide - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - trattament ta ' l-adulti u l-adolexxenti (korp età 12-il sena u aktar antiki mal-piż mill-anqas 35 kg) infettati bil-virus ta ' immunodefiċjenza umani 1 (hiv 1) mingħajr mutazzjonijiet magħrufa assoċjati mal-reżistenza għall-inibitur rivers transcriptase nukleosidi mhux (nnrti) klassi, tenofovir jew emtricitabine u ma a virali jillowdja ≤ 100,000 hiv 1 rna kopji/ml.

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)

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)

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.