Європейський Союз - німецька - EMA (European Medicines Agency)

mylan ireland limited - abirateronacetat - prostata-neoplasmen - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Німеччина - німецька - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - apixaban - filmtablette - 5 mg - teil 1 - filmtablette; apixaban (34778) 5 milligramm

Німеччина - німецька - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - apixaban - filmtablette - 2,5 mg - teil 1 - filmtablette; apixaban (34778) 2,5 milligramm

Європейський Союз - німецька - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - 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. , dreifach-kombinationstherapie) als ergänzung zu diät und bewegung bei patienten, die unzureichend kontrolliert auf ihren maximalen tolerierten dosis von metformin und 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.

Німеччина - німецька - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - sitagliptinhydrochlorid 1 h<2>o - filmtablette - 100 mg - sitagliptinhydrochlorid 1 h<2>o (43765) 113,374 milligramm

Німеччина - німецька - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - sitagliptinhydrochlorid 1 h<2>o - filmtablette - 50 mg - sitagliptinhydrochlorid 1 h<2>o (43765) 56,687 milligramm

Європейський Союз - німецька - EMA (European Medicines Agency)

mylan ireland limited - dimethylfumarat - multiple sklerose, schubförmig-remittierender - immunsuppressiva - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Європейський Союз - німецька - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multiple sklerose, schubförmig-remittierender - immunsuppressiva - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Німеччина - німецька - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - filmtablette - 25 mg

Німеччина - німецька - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan dura gmbh (8006829) - docetaxel - konzentrat zur herstellung einer infusionslösung - teil 1 - konzentrat zur herstellung einer infusionslösung; docetaxel (26819) 40 milligramm