Европска Унија - Мелтешки - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - immunosoppressanti - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Европска Унија - Мелтешки - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazole - skizofrenija - psikolettiċi - trattament ta 'manteniment ta' l-iskiżofrenja f'pazjenti adulti stabbli ma 'aripiprazole orali.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drogi għat-trattament ta 'mard tal-għadam - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. trattament ta ' osteoporożi assoċjat ma sistemiku fit-tul terapija bi glukokortikojdi fil-nisa wara l-menopawża u f'irġiel f'riskju akbar ta'ksur. it-trattament tal-marda ta'paget ta ' l-għadam.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - atazanavir mylan, mogħti flimkien ma 'doża baxxa ta' ritonavir, huwa indikat għall-kura ta 'adulti infettati bl-hiv 1 u pazjenti pedjatriċi ta' 6 snin jew aktar flimkien ma 'prodotti mediċinali antiretrovirali oħra. ibbażat fuq disponibbli viroloġiku u kliniku minn pazjenti adulti, m'hu mistenni ebda benefiċċju f'pazjenti b'razez reżistenti għall-inibituri ta'proteasi multipliċi (≥ 4 mutazzjonijet pi). hemm tagħrif limitat ħafna disponibbli minn tfal ta '6 snin għal inqas minn 18-il sena. l-għażla ta ' atazanavir mylan fl-esperjenza ta'trattament għall-adulti u f'pazjenti pedjatriċi għandu jkun ibbażat fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjent.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinacalcet hydrochloride - hyperparathyroidism, secondary; hypercalcemia - homeostasi tal-kalċju - il-kura ta 'iperparatirojdiżmu sekondarju (hpt) f'pazjenti b'mard renali fl-aħħar stadju (esrd) fuq terapija ta' dijalisi ta 'manteniment. cinacalcet mylan jista 'jintuża bħala parti minn kors terapewtiku li jinkludi binders tal-fosfat u/jew sterols ta' vitamina d, kif xieraq. tnaqqis ta 'iperkalċimja f'pazjenti b': - paratirojde carcinomaprimary hpt li għalihom parathyroidectomywould tkun indikata fuq il-bażi tal-livelli tal-kalċju fis-serum (kif definit mil-linji gwida ta ' kura rilevanti), iżda fejn paratirojdektomija mhiex klinikament xierqa jew kontraindikata.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):għat-trattament ta ' l-hiv-1 infezzjoni fil-kura antiretrovirali (art)-l-esperjenza f'pazjenti adulti, inklużi dawk li ġew ħafna ttrattati minn qabel. għat-trattament ta 'l-hiv-1 infezzjoni fil-pazjenti pedjatriċi mill-eta' ta 3 snin u mill-inqas 15-il kg piż tal-ġisem. id-deċiżjoni li jinbeda it-trattament b'darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir, għandha tingħata konsiderazzjoni kbira lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta 'tibdiliet ġenetiċi assocjati ma' mediċini differenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 u 5. darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir huwa indikat, flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' pazjenti bil-vajrus tal-immunodefiċjenza umana (hiv-1) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. id-deċiżjoni li jinbeda it-trattament b'darunavir f'dawn l-arti-pazjenti b'esperjenza, ġenotipika l-ittestjar għandu jiggwida l-użu ta ' darunavir (ara sezzjonijiet 4. 2, 4. 3, 4. 4 u 5.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

mylan pharmaceuticals limited - duloxetine - neuralgia; diabetic neuropathies; depressive disorder, major; anxiety disorders - psychoanaleptics, - it-trattament tad-disturb tad-depressjoni maġġuri;it-trattament tal-uġigħ newropatiku periferiku dijabetiku;il-kura ta 'disturb ta' ansjetà ġeneralizzata;duloxetine mylan huwa indikat fl-adulti.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mucopolysaccharidosis ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - elaprase huwa indikat għall-kura fit-tul ta ' pazjenti bl-kaċċatur syndrome (mucopolysaccharidosis ii, mps ii). in-nisa eterozigoti ma ġewx studjati fil-provi kliniċi.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

zoetis belgium sa - virus rikombinanti taċ-circovirus porċin (cpcv) 1-2, inattivat - immunoloġiċi - majjali (ħnienes) - immunizzazzjoni attiva ta 'qżieqeż fuq l-età ta' tliet ġimgħat kontra l-virus porcine circovirus tip 2 (pcv2) biex titnaqqas it-tagħbija virali fid-demm u fit-tessuti limfodje, u l-leżjonijiet f'tessuti limfojde assoċjati ma 'infezzjoni b'pcv2, kif ukoll biex tnaqqas sinjali kliniċi - li jinkludu telf ta 'kuljum ta' żieda fil-piż, u l-mortalità assoċjata ma wara l-ftim tal-ġisem, ħela sindromu.