Euroopan unioni - liettua - EMA (European Medicines Agency)

actavis group ptc ehf   - pioglitazono hidrochloridas - cukrinis diabetas, 2 tipas - narkotikai, vartojami diabetu - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. inicijavus terapija su pioglitazone, pacientai turėtų būti peržiūrimas po 3 iki 6 mėnesių, kad įvertint atsaką į gydymą e. sumažinus hba1c). pacientams, kurie nesugeba parodyti tinkamą atsaką, pioglitazone turėtų būti nutrauktas. atsižvelgiant į galimą riziką, ilgai terapija, prescribers turėtų patvirtinti ne vėliau eiliniai nuomonių, kad naudos pioglitazone yra išlaikomas (žr. skyrių 4.

Euroopan unioni - liettua - EMA (European Medicines Agency)

pfizer europe ma eeig - gemtuzumabo ozogamicinas - leukemija, mieloidas, ūmus - antinavikiniai vaistai - mylotarg fluorouracilu ir kartu terapija su daunorubicin (dnr) ir cytarabine (arac) gydomi pacientai, amžiaus 15 ir daugiau metų su anksčiau negydytų, de novo cd33-teigiamas ūminės mieloidinės leukemijos (ppp), išskyrus atvejus, ūmus promyelocytic leukemija (apl).

Euroopan unioni - liettua - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - kiti antineoplastiniai agentai - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Euroopan unioni - liettua - EMA (European Medicines Agency)

lupin europe gmbh - mexiletine hydrochloride - myotonic sutrikimai - Širdies terapija - namuscla fluorouracilu ir simptominis gydymas myotonia suaugusiųjų pacientų su ne dystrophic myotonic sutrikimai.

Euroopan unioni - liettua - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - daugybinė mieloma - antinavikiniai vaistai - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.

Euroopan unioni - liettua - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumabas - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - oftalmologai - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Euroopan unioni - liettua - EMA (European Medicines Agency)

amivas ireland ltd - artesunate - maliarija - antiprotoziniai preparatai - artesunate amivas is indicated for the initial treatment of severe malaria in adults and children. reikėtų atsižvelgti į oficialius nurodymus, kaip tinkamai naudoti vaistus nuo maliarijos sukėlėjų.

Euroopan unioni - liettua - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antinavikiniai vaistai - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Euroopan unioni - liettua - EMA (European Medicines Agency)

bial portela & companhia s.a. - opikaponas - parkinsono liga - anti-parkinsono vaistai - ontilyv is indicated as adjunctive therapy to preparations of levodopa/ dopa decarboxylase inhibitors (ddci) in adult patients with parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Euroopan unioni - liettua - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - daugybinė mieloma - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.