Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskulárna blokáda - všetky ostatné terapeutické produkty - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastické činidlá - imatinib teva b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. o detských pacientov s ph+ cml) v chronickej fáze po neúspechu interferónu-alfa terapia, alebo v zrýchlenej fáze alebo výbuch krízy. dospelých pacientov s ph+ cml v blastickej kríze. , vzdelávanie dospelých a pediatrických pacientov s novo diagnostikovanou chromozóm philadelphia pozitívne acute lymphoblastic leukémia (ph+ all) integrovaný s chemoterapiou. dospelých pacientov s relapsed alebo žiaruvzdorné ph+ all, ako monotherapy. dospelých pacientov s myelodysplastic/myeloproliferative ochorenia (mds/mpd), spojené s krvných doštičiek-derived growth factor receptor (pdgfr) gén re-opatrenia. dospelých pacientov s pokročilým hypereosinophilic syndróm (hes) alebo chronická eozinofilná leukémia (cel) s fip1l1-pdgfra prestavby. Účinok imatinib o výsledku transplantáciu kostnej drene nebola stanovená. imatinib teva b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , adjuvantná liečba dospelých pacientov, ktorí sú na významné riziko relapsu nasledujúce resekcia kit (cd117)-pozitívne tÉmou. pacienti, ktorí majú nízky alebo veľmi nízke riziko opakovania by nemalo prijímať adjuvantná liečba. liečba dospelých pacientov s unresectable dermatofibrosarcoma protuberans (dfsp) a u dospelých pacientov s recidivujúcim a/alebo metastatickým dfsp, ktorí nie sú akceptovateľné pre operácie. , u dospelých a pediatrických pacientov, účinnosť imatinib je založené na celkovej hematologické a cytogenetic odpoveď ceny a postup-zadarmo prežitie v cml, na hematologické a cytogenetic miera odozvy v ph+ all, mds/mpd, na hematologické miera odozvy v hes/cel a na cieľ miera odozvy u dospelých pacientov s unresectable a/alebo metastatickým podstata a dfsp a na opakovanie-free prežitie v adjuvantnej tÉmou. skúsenosti s imatinib u pacientov s mds/mpd spojené s pdgfr gén re-opatrenia je veľmi obmedzený. nie sú žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení.

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

astellas pharma gmbh - tacrolimus - dermatitída, atopická - ostatné dermatologické prípravky - liečba strednej až závažnej atopickej dermatitídy u dospelých, ktorí dostatočne nereagujú na alebo sú konvenčnú liečbu, napríklad lokálnymi kortikosteroidmi. liečba stredne ťažkej až ťažkej atopickej dermatitídy u detí (vo veku 2 roky a starších), ktoré nereagovali adekvátne na konvenčné terapie, ako sú topické kortikosteroidy. Údržba liečbu stredne ťažkej atopickej dermatitídy na prevenciu svetlice a predĺženie flare-free intervaloch u pacientov dochádza k vysokej frekvencii ochorení exacerbations i. vyskytujúce sa 4 alebo viackrát za rok), ktorí mali počiatočnú odpoveď na maximálne 6 týždne liečby dvakrát dennej masti takrolimus (lézie vyčistené, takmer vyčistené alebo mierne postihnuté).

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

bayer ag - riociguat - hypertenzia, pľúca - antihypertenzíva pre pľúcnu arteriálnu hypertenziu - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. Účinnosť bola preukázaná v pau obyvateľstva vrátane aetiologies z idiopatická alebo dedičné pau alebo pah spojené s spojivového tkaniva ochorenia. paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

novartis europharm limited - vildagliptín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, hydrochlorid metformín - diabetes mellitus, typ 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 a 5. 1 pre dostupné údaje o rôznych kombináciách).

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

novartis europharm limited - vildagliptín - diabetes mellitus, typ 2 - dipeptidyl peptidase 4 (dpp-4) inhibitors, drugs used in diabetes - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. 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 a 5. 1 pre dostupné údaje o rôznych kombináciách).

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

novartis europharm limited  - vildagliptin, hydrochlorid metformín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - zomarist 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.

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

novartis europharm limited - vildagliptín - diabetes mellitus, typ 2 - lieky používané pri cukrovke - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. 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 a 5. 1 pre dostupné údaje o rôznych kombináciách).

Liên Minh Châu Âu - Tiếng Slovak - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - karcinóm, pľúc bez malých buniek - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.