Glybera Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glybera

uniqure biopharma b.v.  - alipogene tiparvovec - iperlipoproteinemija tip i - aġenti li jimmodifikaw il-lipidi - glybera huwa indikat għal pazjenti adulti dijanjostikati b'defiċjenza ta 'lipoproteina lipase familjali (lpld) u li jbatu minn attakki severi jew multipli ta' pankreatite minkejja r-restrizzjonijiet tad-dieta tax-xaħam. id-dijanjożi ta 'lpld trid tiġi kkonfermata b'testjar ġenetiku. l-indikazzjoni hija ristretta għal pazjenti b'livelli li jistgħu jiġu osservati ta 'proteina lpl.

NeuroBloc Unjoni Ewropea - Malti - EMA (European Medicines Agency)

neurobloc

sloan pharma s.a.r.l - tossina botulinum tat-tip b - torticollis - rilassanti tal-muskoli - neurobloc huwa indikat għall-kura ta 'distonja ċervikali (torticollis). ara t-taqsima 5. 1 għall-informazzjoni dwar l-effikaċja f'pazjenti li jirrispondu / jirreżistu għal botulinum toxin tip a.

Pixuvri Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pixuvri

les laboratoires servier - pixantrone dimaleate - limfoma, mhux hodgkin - aġenti antineoplastiċi - pixuvri huwa indikat bħala monoterapija għat-trattament ta 'pazjenti adulti li għandhom limfomi ċellulari b mhux multipli li jirkadu jew refrattarji aggressivi (nhl). il-benefiċċju tat-trattament ta 'pixantrone ma ġiex stabbilit f'pazjenti meta jintuża bħala kimoterapija tal-ħames linja jew ikbar f'pazjenti li huma refrattorji għall-aħħar terapija.

Vildagliptin / Metformin hydrochloride Accord Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vildagliptin / metformin hydrochloride accord

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 u 5. 1 għad-data disponibbli dwar kombinazzjonijiet differenti).

Sitagliptin / Metformin hydrochloride Accord Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sitagliptin / metformin hydrochloride accord

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.

Sitagliptin / Metformin hydrochloride Mylan Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sitagliptin / metformin hydrochloride mylan

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan 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. sitagliptin/metformin hydrochloride mylan 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. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan 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.

Icandra (previously Vildagliptin / metformin hydrochloride Novartis) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

icandra (previously vildagliptin / metformin hydrochloride novartis)

novartis europharm limited - vildagliptin, metformin hydrochloride - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 u 5. 1 għad-data disponibbli dwar kombinazzjonijiet differenti).

Sitagliptin / Metformin hydrochloride Sun Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sitagliptin / metformin hydrochloride sun

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun 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. sitagliptin/metformin hydrochloride sun 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. sitagliptin/metformin hydrochloride sun 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. sitagliptin/metformin hydrochloride sun 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.

Evista Unjoni Ewropea - Malti - EMA (European Medicines Agency)

evista

substipharm - raloxifene hydrochloride - l-osteoporożi, il-menopawża - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - evista huwa indikat għat-trattament u l-prevenzjoni tal-osteoporożi f'nisa wara l-menopawża. Ġie muri tnaqqis sinifikanti fl-inċidenza ta 'ksur vertebrali, iżda mhux tal-ġenbejn. when determining the choice of evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Optruma Unjoni Ewropea - Malti - EMA (European Medicines Agency)

optruma

eli lilly nederland b.v. - raloxifene hydrochloride - l-osteoporożi, il-menopawża - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - optruma huwa indikat għat-trattament u l-prevenzjoni tal-osteoporożi f'nisa wara l-menopawża. Ġie muri tnaqqis sinifikanti fl-inċidenza ta 'ksur vertebrali, iżda mhux tal-ġenbejn. meta jiġi stabbilit l-għażla ta ' l-optruma jew l-oħra t-terapiji, inklużi oestrogens, għall-mara postmenopausal individwali, konsiderazzjoni għandha tingħata għal sintomi menopausal, effetti fuq uterini u s-sider tessuti, u r-riskji kardjovaskulari u benefiċċji (ara taqsima 5.