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)

takeda pharma a/s - azilsartan medoxomil - Хипертония - Агенти, действащи върху системата ренин-ангиотензин - edarbi е показан за лечение на есенциална хипертония при възрастни.

Европейски съюз - български - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin, пиоглитазон - Захарен диабет тип 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i. тройната комбинирана терапия) като допълнение към диета и физически упражнения за подобряване на гликемичния контрол при възрастни пациенти (в частност, пациенти с наднормено тегло) е неадекватен на тяхното максимално переносимой дозата на метформина и пиоглитазона. Освен това , incresync може да се използва за да замени отделни хапчета alogliptin и пиоглитазон в тези възрастни пациенти на възраст на 18 и повече години с dm-2 вече е диабет, лекувани с тази комбинация. След започване на терапия с incresync, пациентите трябва да се преразгледа след три до шест месеца, за да се оцени адекватността на отговорите на лечение (e. намаляване на показателите на hba1c). При пациенти, които не показват адекватен отговор, трябва да спре да incresync. В светлината на потенциалните рискове при продължително пиоглитазон терапия, се предписват лекарства трябва да се потвърди в следващите рутинни проверки, което е в полза на incresync се запазват (виж раздел 4.

Европейски съюз - български - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin бензоат, метформина хидрохлорид - Захарен диабет тип 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;in combination with pioglitazone (i. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;in combination with insulin (i. тройната комбинирана терапия) като допълнение към диета и физически упражнения за подобряване на гликемичния контрол при пациенти, когато на инсулин в стабилна доза и метформин самостоятелно не осигуряват адекватен гликемичен контрол.

Европейски съюз - български - EMA (European Medicines Agency)

takeda pharma a/s - алоглиптин - Захарен диабет тип 2 - drugs used in diabetes, dipeptidyl peptidase 4 (dpp-4) inhibitors - vipidia е показан при възрастни, навършили 18 години и по-големи с тип 2 захарен диабет за подобряване на гликемичния контрол в комбинация с други глюкоза, понижаване на лекарствени продукти, включително инсулин, когато те, заедно с диета и упражнения, не осигуряват адекватна гликемичния контрол (виж раздели 4. 4, 4. 5 и 5. 1 за наличните данни за различни комбинации).

Европейски съюз - български - EMA (European Medicines Agency)

endoceutics s.a. - Лекарството прастерона - postmenopause - Други полови хормони, и слиза полова система - intrarosa е показан за лечение на вулварна и вагинална атрофия при постменопаузални жени с умерени до тежки симптоми.

Европейски съюз - български - EMA (European Medicines Agency)

sanofi b.v. - тиротропин алфа - Тироидни неоплазми - Хормони на предния дял на хипофизата и аналози, хипофизата и гипоталамические хормони и аналози - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.

Европейски съюз - български - EMA (European Medicines Agency)

laboratoires smb s.a. - фенофибрат, Правастатин - Дислипидемиите - Липидни модифициращи агенти - pravafenix е показан за лечение на високо-коронарните--болест на сърцето (ИБС)-риск възрастни пациенти със смесена дислипидемия, характеризиращи се с високи триглицериди и ниски нива на hdl-cholesterol (c), чиито нива на ldl-c са адекватно контролирани докато на лечение с монотерапия pravastatin-40-мг.

Европейски съюз - български - EMA (European Medicines Agency)

recordati ireland ltd - силодозин - Простатна хиперплазия - urologicals - Лечението на признаците и симптомите на доброкачествена простатна хиперплазия (БПХ).

Европейски съюз - български - EMA (European Medicines Agency)

astrazeneca ab - glycopyrronium, formoterol fumarate dihydrate - Белодробна болест, хронична обструктивна болест - формотерол и бромид glycopyrronium - bevespi атмосфера е показан като поддържаща терапия с бронходилататор за облекчаване на симптомите при възрастни пациенти с хронична обструктивна болест на белия дроб (хронична обструктивна белодробна болест).