האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

astrazeneca ab - olaparib - Овариални неоплазми - Антинеопластични средства - Яйчниците cancerlynparza включен като монотерапии за:подкрепа на лечение на възрастни пациенти с късни (фиго етапи iii и iv) в гените brca1/2-мутирали (зародышевой линия и/или соматични) высокосортная епител на яйчника, маточната тръба или начална перитонеална рак, които в отговор (пълна или частична) след приключване на първа линия на базата на платина химиотерапия. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 и 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. Пациентите трябва предварително са обработени с антрациклина и таксана в (нео)помощните или метастатический, ако пациентите не са подходящи за тези процедури (виж раздел 5. Пациентите с рецептор хормон (ч)-положителен рак на гърдата трябва също така да развиват или след предварителна хормонална терапия, или се считат за неподходящи за ендокринна терапия. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ламивудин - Хепатит В, хроничен - Антивирусни средства за системно приложение - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. Начало лечение ламивудином трябва да бъдат само в случай, че използването на алтернативни антивирусни агенти с по-висок генетичен бариера не са достъпни или подходящи;, декомпенсированной заболяване на черния дроб в съчетание с втория агент, без кръстосана резистентност към ламивудину.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - Антинеопластични средства - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - Карцином, недребноклетъчен белодроб - Други противоракови лекарства, инхибитори на протеинкиназы - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - Диагностични радиофармацевтици - Този лекарствен продукт е само за диагностична употреба. След radiolabelling с галлием (68га) разтвор на хлорид, разтвор на галий (68га) edotreotide получени предназначени за позитронна-емисионна томография (pet) визуализация на рецепторите на соматостатин сверхэкспрессия при възрастни пациенти с потвърдена или предполагаема высокодифференцированных стомашно-enteropancreatic нейроэндокринные тумори (gap-net) за локализиране на първични тумори и техните метастази.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

astrazeneca ab - метформина хидрохлорид, монохидрат dapagliflozin пропандиол - Захарен диабет тип 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo е показан при възрастни за лечение на захарен диабет тип 2, като допълнение към диета и упражнения:• при пациенти, недостатъчно контролирани за тяхното максимално переносимой доза само метформина • в комбинация с други лекарствени средства за лечение на захарен диабет при пациенти, недостатъчно контролирани метформином и тези лекарствени средства• при пациенти, вече лечившихся комбинация dapagliflozin и метформина като отделни таблетки. Според резултатите от проучване по отношение на комбинирана терапия, влияние върху гликемичния контрол и сърдечно-съдови събития, както в добре проучените групи, вижте раздели 4. 4, 4. 5 и 5.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

astrazeneca ab - Саксаглиптин - Захарен диабет тип 2 - Лекарства, използвани при диабет - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

les laboratoires servier - ивабрадин хидрохлорид - angina pectoris; heart failure - Сърдечна терапия - Симптоматично лечение на хронична стабилна ангина пекторис ivabradine е показан за симптоматично лечение на хронична стабилна ангина пекторис в коронарна артерия болест възрастни с нормален синусов ритъм и сърдечната честота ≥ 70 bpm. ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Лечение на хронична сърдечна недостатъчност ivabradine е посочена в хронична сърдечна недостатъчност nyha ii до iv клас със систолното дисфункция, при пациентите в синусов ритъм и чиито пулс е ≥ 75 bpm, в комбинация със стандартна терапия, включително бета-блокер терапия или Когато терапия с бета-блокер е противопоказано или не понася.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

novartis europharm limited - вилдаглиптин - Захарен диабет тип 2 - Лекарства, използвани при диабет - 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 и 5. 1 за наличните данни за различни комбинации).

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - Простатни неоплазми - Ендокринна терапия - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.