Европейски съюз - български - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - тиотепа - hematopoietic stem cell transplantation; neoplasms - Антинеопластични средства - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Европейски съюз - български - 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.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - астма - Лекарства за обструктивна заболявания на дихателните пътища, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services limited - umeclidinium bromide - Белодробна болест, хронична обструктивна болест - Лекарства за обструктивна заболявания на дихателните пътища, - rolufta е показан като поддържащо бронходилататорно лечение за облекчаване на симптомите при възрастни пациенти с хронично обструктивно белодробно заболяване (copd).

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services limited - флутиказон фуроат, umeclidinium бромид vilanterol trifenatate - Белодробна болест, хронична обструктивна болест - Лекарства за обструктивна заболявания на дихателните пътища, - elebrato ellipta е посочено като поддържащо лечение при възрастни пациенти с умерена до тежка хронична обструктивна белодробна болест (ХОББ), които не са третирани адекватно чрез комбинация на инхалаторни кортикостероиди и дългодействащ β2-агонист.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services - флутиказон фуроат, umeclidinium бромид vilanterol trifenatate - Белодробна болест, хронична обструктивна болест - Лекарства за обструктивна заболявания на дихателните пътища, - trelegy ellipta е посочено като поддържащо лечение при възрастни пациенти с умерена до тежка хронична обструктивна белодробна болест (ХОББ), които не са третирани адекватно чрез комбинация на инхалаторни кортикостероиди и дългодействащ β2-агонист.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services limited - zanamivir - Грип, Човек - Антивирусни средства за системно приложение - dectova е показан за лечение на сложни и потенциално опасни за живота на грип a или b вирусна инфекция при възрастни и педиатрични пациенти (на възраст ≥6 месеца), когато:болен от грип вирус може да бъде устойчив на противогриппозных лекарствени продукти, различни от zanamivir, и/или на антивирусни лекарства за лечение на грип, включително и на инхалаторен zanamivir, не са подходящи за конкретния пациент.. dectova трябва да се използва в съответствие с официалните насоки.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services limited - флутиказон фуроат, umeclidinium бромид vilanterol trifenatate - Белодробна болест, хронична обструктивна болест - Лекарства за обструктивна заболявания на дихателните пътища, - temybric ellipta посочва като поддържаща терапия при възрастни пациенти с умерена до тежка хронична обструктивна болест на белия дроб (хронична обструктивна белодробна болест), които не се лекува правилно комбинация ингаляционных кортикостероид и дълго действащ β2-агонист или комбинация от дълго действащ β2-агонист и длинн-действа мускаринового антагонист (за въздействие върху симптом за контрол и превенция на изостряне виж раздел 5.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - Имунни серуми и имуноглобулини - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline trading services limited - albiglutide - Захарен диабет тип 2 - Лекарства, използвани при диабет - eperzan е показан за лечение на захарен диабет тип 2 при възрастни за подобряване на гликемичния контрол, като:monotherapywhen диета и физически упражнения сам не осигуряват адекватен гликемичен контрол при пациенти, за които прилагането на метформина се счита за непрактично поради противопоказания или непоносимост. Добави в комбинация от терапия в комбинация с други сахароснижающих лекарства, включително и на базалния инсулин, когато те, заедно с диета и физически упражнения не гарантират адекватен гликемичен контрол (виж раздел 4. 4 и 5. 1 за наличните данни за различни комбинации).