Unia Europejska - bułgarski - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - Неоплазми на гърдата - Антинеопластични средства - piqray, се посочва в комбинация с фулвестрант за лечение на жени след менопауза и мъже, с хормон рецептори (pr)-положителен, хорско эпидермическое приемащото устройство 2 фактор на растежа (her2 и)-отрицателен, локално-напреднал или метастазирал рак на млечната жлеза с мутация pik3ca след прогресия на заболяването след хормонална терапия, тъй като монотерапии (вж. раздел 5.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

alfasigma s.p.a. - метилтионинов хлорид - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - Левкемия, миелогенна, хронична, bcr-abl положителна - Антинеопластични средства - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - Невромускулна блокада - Всички други терапевтични продукти - 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.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - sugammadex sodium - Невромускулна блокада - Всички други терапевтични продукти - 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.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

extrovis eu ltd. - sugammadex sodium - Невромускулна блокада - Всички други терапевтични продукти - 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.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

piramal critical care b.v. - sugammadex sodium - Невромускулна блокада - сугамадекс - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - Невромускулна блокада - Всички други терапевтични продукти - Възстановяване на нервно-мускулната блокада, предизвикана от рокурония или векурония. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

accord healthcare s.l.u. - иматиниб - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - иматиниб - imatinib accord is indicated for the treatment of- adult and 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. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. С изключение първи път е идентифицирана хронична фаза на ХМЛ, няма контролирани проучвания, които показват клиничен ефект, или увеличава процента на преживяемост при тези заболявания. .

Unia Europejska - bułgarski - EMA (European Medicines Agency)

actavis group ptc ehf - иматиниб - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. Ефект иматиниба на резултата от трансплантация на костен мозък не се определя. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. Опит с иматинибом при пациенти с миелодиспластичен синдром/МПЗ, свързани с pdgfr генетични комбинации-много ограничен. Няма контролирани проучвания показват клинична полза или преживяемост при тези заболявания,.