Avrupa Birliği - Bulgarca - EMA (European Medicines Agency)

novartis europharm limited - травопрост - glaucoma, open-angle; ocular hypertension - Офталмологични - Намаляване на повишеното вътреочно налягане при възрастни пациенти с очна хипертензия или глаукома с отворен ъгъл (виж раздел 5. Намаляване на повишено вътреочното налягане при педиатрични пациенти на възраст от 2 месеца преди < 18 години с очна хипертония или детска глаукома (виж раздел 5.

Avrupa Birliği - Bulgarca - EMA (European Medicines Agency)

santen oy - netarsudil - glaucoma, open-angle; ocular hypertension - Офталмологични - Намаляване на повишено вътреочното налягане (ВОН) при възрастни пациенти с първична откритоъгълна глаукома или очна хипертония.

Avrupa Birliği - Bulgarca - EMA (European Medicines Agency)

intervet international bv - индоксакарб - ectoparasiticides за външно приложение, включително. инсектициди, indoxacarb - dogs; cats - Лечение и предотвратяване на инфекция с бълхи. За кучета и котки: Лечение и профилактика на заразяване с бълхи. Ветеринарният лекарствен продукт може да бъде използван като част от терапевтична стратегия за алергичен дерматит против бълхи. Развитието на стадиите на бълхи в непосредствената околна среда на домашния любимец се убива след контакт с животни, третирани с activyl.

Avrupa Birliği - Bulgarca - EMA (European Medicines Agency)

beevital gmbh - оксалова киселина дигидрат, мравчена киселина - ectoparasiticides за външно приложение, включително. инсектициди - Пчелите - Лечение varroosis (Варроа деструктор) в мед пчелните семейства без потомство.

Avrupa Birliği - Bulgarca - 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. .

Avrupa Birliği - Bulgarca - EMA (European Medicines Agency)

koanaa healthcare gmbh - иматиниба мезилат - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Антинеопластични средства - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. 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. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. 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.

Avrupa Birliği - Bulgarca - 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.

Avrupa Birliği - Bulgarca - EMA (European Medicines Agency)

eco animal health europe limited - тилвалозин - Противоинфекционные за системна употреба на антибактериални лекарства за системна употреба макролиди - pheasants; chicken; turkeys; pigs - pigstreatment и methaphylaxis прасета энзоотической пневмония;Лечение на свински пролиферативной энтеропатии (илеит);лечение и methaphylaxis дизентерия прасета. chickenstreatment и methaphylaxis респираторни заболявания, свързани с галисептикум микоплазмоза на кокошките,. pheasantstreatment респираторни заболявания, свързани с галисептикум микоплазма . turkeystreatment респираторни заболявания, свързани с tylvalosin чувствителни щамове ornithobacterium rhinotracheale на пуйки.

Avrupa Birliği - Bulgarca - 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,.

Avrupa Birliği - Bulgarca - EMA (European Medicines Agency)

orion corporation - dexmedetomidine hydrochloride - Нервната система, други хипнотици и успокоителни - Кучета - За облекчаване на остра тревожност и страх, свързани със шума при кучета.