Европейски съюз - български - EMA (European Medicines Agency)

torbet laboratories ireland limited - urea (13c) - breath tests; helicobacter infections - Диагностични агенти - Този лекарствен продукт е само за диагностична употреба. За прижизненной диагностика гастродуоденальных Хеликобактер пилори (h.. pylori) инфекции на.

Европейски съюз - български - EMA (European Medicines Agency)

infai, institut für biomedizinische analytik nmr-imaging gmbh - urea (13c) - breath tests; helicobacter infections - Диагностични агенти - Хеликобактер test infai може да се използва за прижизненного диагноза гастродуоденальной зона helicobacter pylori инфекция:възрастни;тийнейджъри, които, вероятно, са на язвена болест. Хеликобактер test infai за деца на възраст от три до 11 години може да се използва за прижизненного диагноза gastrduodenal helicobacter pylori инфекция:за измерване на успеха на эрадикационной терапия, или когато неинвазивни тестове не могат да бъдат изпълнени или когато има дискордантные резултати, произтичащи от инвазивни тестове. Този лекарствен продукт е само за диагностична употреба.

България - български - Изпълнителна агенция по лекарствата

dr theiss naturwaren gmbh - echinacea purpurea - 75,6 ml/100 ml oral drops, solution

Европейски съюз - български - EMA (European Medicines Agency)

elanco gmbh - робенакоксиб - anti-inflammatory and anti-rheumatic products, non-steroids, coxibs - dogs; cats - Котки (хапчета):за treatmentrelief на болката и възпалението, свързани с остра или хронична патология на опорно-двигателния апарат. За да се намали до умерена болка и възпаление, свързани с ортопедична хирургия. Кучета (хапчета):за лечение на болка и възпаление, свързани с хронична остеоартроза. За лечение на болка и възпаление, свързани с хирургия на меките тъкани . Котки и кучета (инжектиране):за лечение на болка и възпаление, свързани с ортопедични и хирургия на меките тъкани.

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)

novartis europharm limited - crizanlizumab - Анемия, сърповидна клетка - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Европейски съюз - български - 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.

Европейски съюз - български - EMA (European Medicines Agency)

astrazeneca ab - екзенатид - Захарен диабет тип 2 - Лекарства, използвани при диабет - bydureon, се посочва в възрастни от 18 години и по-възрастни с диабет тип 2, за подобряване на контрол доведе до бъбречна недостатъчност в комбинация с други глюкоза, намаляване на лекарствени продукти при терапия при използване заедно с диета и физически упражнения не осигурява адекватен контрол доведе до бъбречна недостатъчност (виж раздел 4. 4, 4. 5 и 5. 1 за наличните данни за различни комбинации). bydureon е показан при лечение на захарен диабет тип 2 в комбинация с:metforminsulphonylureathiazolidinedionemetformin и sulphonylureametformin и thiazolidinedionein възрастни, които не са достигнали до адекватен гликемичен контрол на максимално переносимой дози от тези устни терапии.

Европейски съюз - български - EMA (European Medicines Agency)

actavis group ptc ehf    - пиоглитазон хидрохлорид - Захарен диабет тип 2 - Лекарства, използвани при диабет - pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:as monotherapy:in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Пиоглитазон също така е показано за комбинация с инсулин на тип 2 диабет при възрастни пациенти с недостатъчен контрол доведе до бъбречна недостатъчност на инсулин, за които метформин е непрактично, поради противопоказания или непоносимост. След започване на терапия с пиоглитазоном, пациентите трябва да бъдат преразгледани през 3-6 месеца за оценка на адекватността на отговора на лечение (e. намаляване на показателите на hba1c). При пациенти, които не показват адекватен отговор, трябва да отмени пиоглитазон. В светлината на потенциалните рискове при продължително лечение, се предписват лекарства трябва да се потвърди в следващите рутинни проверки, което е в полза на пиоглитазон се запазва.

Европейски съюз - български - EMA (European Medicines Agency)

actavis group ptc ehf   - пиоглитазон хидрохлорид - Захарен диабет тип 2 - Лекарства, използвани при диабет - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. След започване на терапия с пиоглитазоном, пациентите трябва да бъдат преразгледани през 3-6 месеца за оценка на адекватността на отговора на лечение (e. намаляване на показателите на hba1c). При пациенти, които не показват адекватен отговор, трябва да отмени пиоглитазон. В светлината на потенциалните рискове при продължително лечение, се предписват лекарства трябва да се потвърди в следващите рутинни проверки, което е в полза на пиоглитазон се запазват (виж раздел 4.