Европейски съюз - български - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - pegunigalsidase alfa - Фабри болест - Други стомашно-чревния тракт и обмяната на веществата средства, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Европейски съюз - български - EMA (European Medicines Agency)

biopartners gmbh - recombinant human interferon alfa-2a - Хепатит c, хроничен - Иммуностимуляторы, - adult patients with histologically proven chronic hepatitis c who are positive for hepatitis c virus (hcv) antibodies or hcv rna and have elevated serum alanine aminotransferase (alt) without liver decompensation. the efficacy of interferon alfa-2a in the treatment of hepatitis c is enhanced when combined with ribavirin. alpheon should be given alone mainly in case of intolerance or contra-indication to ribavirin.

Европейски съюз - български - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - Антинеопластични средства - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Европейски съюз - български - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - пеметрексед динатриев хемипентахидрат - carcinoma, non-small-cell lung; mesothelioma - Антинеопластични средства - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ciambra включен като монотерапии за лечение на местнораспространенного или метастатичен немелкоклеточного рак на белите дробове, други, предимно от плоскоклетъчен хистология при пациенти със заболяване на които не прогрессировало веднага след платиносодержащей химиотерапия. ciambra включен като монотерапии за втора линия на лечение при пациенти с локално-напреднал или метастазирал немелкоклеточным рак на белите дробове, отколкото други са в основата на плоскоклеточной гистологией.

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)

ferring pharmaceuticals a/s - дегареликс - Простатни неоплазми - Ендокринна терапия - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

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)

pfizer europe ma eeig  - акситиниб - Карцином, бъбречна клетка - Инхибитори на протеинкиназы - inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) after failure of prior treatment with sunitinib or a cytokine.