Европейски съюз - български - EMA (European Medicines Agency)

recordati rare diseases - Бетаин безводен - Хомоцистинурията - Други стомашно-чревния тракт и обмяната на веществата средства, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag - aflibercept - wet macular degeneration; macular edema; diabetes complications - Офталмологични - Эйлеа е показан за възрастни за лечение на:неоваскулярной (влажна) на възрастовата макулна дегенерация (amd);нарушения на зрението, вследствие на оток на макулата вторично запушване ретинальных вени (клон или централна РДЛ РДЛ);нарушения на зрението, вследствие на диабетического оток на макулата (ДМО);нарушения на зрението, вследствие на миопической хориоидальной неоваскуляризации (миопической ХНВ).

Европейски съюз - български - EMA (European Medicines Agency)

astrazeneca ab - фулвестрант - Неоплазми на гърдата - Ендокринната терапия, антиэстрогены - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. В пре - или менопауза, в комбинираното лечение с palbociclib трябва да се комбинира с lhrh лутеинизиращ хормон освобождаващ хормон (lhrh) агонист.

Европейски съюз - български - EMA (European Medicines Agency)

novartis europharm limited - иматиниб - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - Антинеопластични средства - glivec 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-pdgfra rearrangement. Ефект Гливека за изхода на трансплантацията на костен мозък все още не е определен. glivec is indicated for: , 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. Пациентите, които имат нисък или много нисък риск от рецидив не трябва да получават помощните терапия; лечение на възрастни пациенти с метастатичен выбухающей dermatofibrosarcoma (dfsp) и възрастни пациенти с пристъпно и / или метастатичен dfsp, които не са допустими за операция. При възрастни и педиатрични пациенти, на ефективността на Гливек се основава на общите гематологических и цитогенетических отговор и преживяемост без прогресия при ХМЛ, хематологични и цитогенетический отговор на цените на ph+ all, миелодиспластичен синдром / МПЗ, на гематологические показатели за обратна връзка в ХЕС / човек и на обективен отговор при възрастни пациенти с неоперабельными и / или метастатическими Гист и dfsp и на безрецидивную преживяемост при помощните същността на. Опит Гливек при пациенти с миелодиспластичен синдром / МПЗ, свързани с pdgfr генетични комбинации-много ограничен (виж раздел 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.

Европейски съюз - български - 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. .

Европейски съюз - български - 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,.

Европейски съюз - български - EMA (European Medicines Agency)

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - Имунологични средства за суици - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. Друг ключов фактор, допринасящ за разяждането на глиган, skatole, също може да бъде намален като косвен ефект. Агресивното и сексуално (монтажно) поведение също се намалява. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).

Европейски съюз - български - EMA (European Medicines Agency)

elanco gmbh - pegbovigrastim - Колониестимулирующие фактори, иммуностимуляторы, анти-туморни агенти - cattle (cows and heifers); cattle - Като помощ в програма за управление на стадата, да се намали рискът от клиничен мастит при перикарртиеви крави и юници през 30-те дни след отелването.

Европейски съюз - български - EMA (European Medicines Agency)

eisai gmbh - ленавиниб месилат - Карцином, бъбречна клетка - Антинеопластични средства - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Европейски съюз - български - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - Неутропения - Иммуностимуляторы, , колониестимулирующие фактори - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).