Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 13056 oxykodon-hydrochlorid; 12409 dihydrÁt naloxon-hydrochloridu - tableta s prodlouženým uvolňováním - 20mg/10mg - oxykodon a naloxon

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 13056 oxykodon-hydrochlorid; 12409 dihydrÁt naloxon-hydrochloridu - tableta s prodlouženým uvolňováním - 40mg/20mg - oxykodon a naloxon

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 10722 topiramÁt - potahovaná tableta - 100mg - topiramÁt

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 10722 topiramÁt - potahovaná tableta - 25mg - topiramÁt

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 10722 topiramÁt - potahovaná tableta - 50mg - topiramÁt

Uniunea Europeană - cehă - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, typ 2 - léky užívané při diabetu - 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. trojkombinační léčbě) jako doplněk k dietním opatřením a cvičení u pacientů nedostatečně maximální tolerované dávky metforminu a sulfonylmočoviny. 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.

Uniunea Europeană - cehă - EMA (European Medicines Agency)

mylan ireland limited - lenalidomid - mnohočetný myelom - imunosupresiva - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Uniunea Europeană - cehă - EMA (European Medicines Agency)

mylan ireland limited - abirateron acetátu - prostatetické novotvary - 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.

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 8840 amisulprid - tableta - 200mg - amisulprid

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 8840 amisulprid - tableta - 50mg - amisulprid