Euroopan unioni - puola - EMA (European Medicines Agency)

accord healthcare s.l.u. - arypiprazol - schizophrenia; bipolar disorder - psycholeptyki - aripiprazole accord jest wskazany w leczeniu schizofrenii u dorosłych i młodzieży w wieku 15 lat i starszych. arypiprazol umowy jest wskazany w leczeniu umiarkowanych do ciężkich epizodów maniakalnych w zaburzenia lękowe i dla zapobiegania nowego notoryczny odcinek u osób dorosłych, które doświadczyły głównie epizody maniakalne i których epizody maniakalne odpowiedział na arypiprazol w leczeniu. arypiprazol zgody jest wskazany do leczenia do 12 tygodni umiarkowanych i ciężkich epizodów maniakalnych w dwubiegunowa u młodzieży w wieku od 13 lat i powyżej.

Espanja - espanja - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

accord healthcare s.l.u. - pantoprazol sodico sesquihidrato - polvo para soluciÓn inyectable - 40 mg - pantoprazol sodico sesquihidrato 40 mg - pantoprazol

Euroopan unioni - unkari - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - daganatellenes szerek - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Italia - italia - AIFA (Agenzia Italiana del Farmaco)

accord healthcare, s.l.u. - topiramato - topiramato

Euroopan unioni - kreikka - EMA (European Medicines Agency)

accord healthcare s.l.u. - αριπιπραζόλη - schizophrenia; bipolar disorder - Ψυχοληπτικά - Το aripiprazole accord ενδείκνυται για τη θεραπεία της σχιζοφρένειας σε ενήλικες και σε εφήβους ηλικίας 15 ετών και άνω. Η αριπιπραζόλη accord ενδείκνυται για τη θεραπεία ήπιων έως σοβαρών μανιακών επεισοδίων σε Διπολική Διαταραχή τύπου ι και για την πρόληψη νέου μανιακού επεισοδίου σε ενήλικες που εμφάνισαν κυρίως μανιακά επεισόδια και των οποίων τα μανιακά επεισόδια ανταποκρίθηκαν στη θεραπεία με αριπιπραζόλη. Η αριπιπραζόλη accord ενδείκνυται για τη θεραπεία έως και 12 εβδομάδες με μέτρια έως σοβαρά μανιακά επεισόδια στη Διπολική Διαταραχή τύπου ι σε εφήβους ηλικίας 13 ετών και άνω.

Euroopan unioni - italia - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazolo - schizophrenia; bipolar disorder - psicolettici - aripiprazolo accord è indicato per il trattamento della schizofrenia negli adulti e negli adolescenti di età pari o superiore a 15 anni. aripiprazole accord è indicato per il trattamento di moderata a grave episodi maniacali nel disturbo bipolare e per la prevenzione di un nuovo episodio maniacale in adulti che hanno sperimentato episodi maniacali prevalentemente e i cui episodi maniacali risposto alla aripiprazole trattamento. aripiprazole accord è indicato per il trattamento fino a 12 settimane di moderate a gravi episodi maniacali nel disturbo bipolare negli adolescenti di età compresa tra 13 anni e più vecchi.

Euroopan unioni - unkari - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, 2. típus - cukorbetegségben szedett gyógyszerek - for adult patients with type 2 diabetes mellitus, sitagliptin accord 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 (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary 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 ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord 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.

Euroopan unioni - portugali - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazole - schizophrenia; bipolar disorder - psicolepticos - o aripiprazole accord está indicado para o tratamento da esquizofrenia em adultos e em adolescentes de 15 anos ou mais. aripiprazole acordo é indicado para o tratamento de moderados a graves episódios maníacos em transtorno bipolar i e para a prevenção de um novo episódio de mania em adultos que sofreram predominantemente episódios maníacos e cujos episódios maníacos respondeu ao aripiprazol tratamento. aripiprazole acordo é indicado para o tratamento de até 12 semanas de moderados a graves episódios maníacos em transtorno bipolar i em adolescentes com idade de 13 anos e mais velhos.

Euroopan unioni - saksa - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - for adult patients with type 2 diabetes mellitus, sitagliptin accord 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 (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary 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 ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord 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.

Euroopan unioni - saksa - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazol - schizophrenia; bipolar disorder - psycholeptika - aripiprazole accord ist indiziert für die behandlung von schizophrenie bei erwachsenen und bei jugendlichen im alter von 15 jahren und älter. aripiprazole accord ist indiziert für die behandlung von mäßigen bis schweren manischen episoden bei bipolar-i-störung und für die prävention einer neuen manischen episode bei erwachsenen, die erfahrenen, die überwiegend manische episoden und deren manische episoden reagierte auf aripiprazol-behandlung. aripiprazole accord ist indiziert für die behandlung von bis zu 12 wochen von mäßigen bis schweren manischen episoden bei bipolar-i-störung bei jugendlichen ab 13 jahre und älter.