Unión Europea - búlgaro - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - Кистозна фиброза - Други продукти на дихателната система - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Unión Europea - búlgaro - EMA (European Medicines Agency)

mylan ireland limited - азацитидин - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Антинеопластични средства - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Unión Europea - búlgaro - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - етанерцепт - arthritis, rheumatoid; arthritis, juvenile rheumatoid; arthritis, psoriatic; spondylarthropathies; spondylitis, ankylosing; psoriasis - Имуносупресори - rheumatoid arthritisnepexto in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. nepexto може да бъде дадено като монотерапии в случай на непоносимост към метотрексат или при продължително лечение с метотрексат е неподходящо.  nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. nepexto, самостоятелно или в комбинация с метотрексат, е доказано, за да се намали скоростта на прогресия на увреждане на ставите как се измерва с рентгенови и подобряване на физическата функция. Идиопатична arthritistreatment младежки полиартрит (ревматоиден фактор положителен или отрицателен) и разширен олигоартрит при деца и юноши на възраст от 2 години, които са имали недостатъчен отговор или които се оказаха нетерпимыми, метотрексат. Лечение на псориатичен артрит при тийнейджъри на възраст от 12 години, които са имали недостатъчен отговор или които са нетерпимыми, метотрексат. Лечение на артрит, асоцииран с энтезитом при юноши на възраст от 12 години, които са имали недостатъчен отговор или които се оказаха нетерпимыми, традиционната терапия. Этанерцепта не е проучена при деца на възраст по-малко от 2 години. Псориатичен arthritistreatment активно и прогресивното псориатичен артрит при възрастни, когато в отговор на предишния заболевани-усъвършенстват antirheumatic отвари терапия е неадекватна.. Этанерцепт е доказано, че подобрява физическата функция при пациенти с псориатическим артрит, а за да се намали скоростта на прогресията на периферното на ставите, измерена с помощта на рентген при пациенти с полиартикулярным вариант симетрични подтипове заболявания. axial spondyloarthritisankylosing spondylitis treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Не-рентгенографического аксиални спондилоартрита лечение на възрастни с тежки не-рентгенографического аксиални спондилоартрита с обективни признаци на възпаление като показва повишен С-реактивен протеин (crp) и/или ядрено-магнитен резонанс (ЯМР) на показания, които са неадекватни реакции на нестероидни противовъзпалителни средства (НСПВС). Дъска psoriasistreatment възрастни с умерена до тежка форма на плака псориазис, които не са успели да се отговори, или които имат противопоказания или непоносимост към друга системна терапия, включително циклоспорин, метотрексат или psoralen и ултравиолетова а светлина (ПУВА). Детска psoriasistreatment борда на хронични тежки бляшечного на псориазис при деца и юноши на възраст от 6 години, които са недостатъчно контролирани от, или не се толерира, други системни терапии, или phototherapies.

Unión Europea - búlgaro - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - Кистозна фиброза - Други продукти на дихателната система - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Unión Europea - búlgaro - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - Множествена миелома - Антинеопластични средства - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Unión Europea - búlgaro - EMA (European Medicines Agency)

theramex ireland limited - терипаратид - Остеопорозата - Калциева хомеостаза - livogiva is indicated in adults. Лечение на остеопороза при жени в постменопауза и при мъже с повишен риск от фрактури. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Лечение на остеопороза, свързан с постоянна и системна терапия глюкокортикоидами, при жените и мъжете при повишен риск от фрактури.

Unión Europea - búlgaro - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - инсулин аспарт - Захарен диабет - Лекарства, използвани при диабет - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Unión Europea - búlgaro - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - Ангиоедем, наследствено - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Unión Europea - búlgaro - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Unión Europea - búlgaro - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Антинеопластични средства - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.