Opdivo Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

opdivo

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.

Infanrix Penta Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

infanrix penta

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - Ваксини - infanrix penta е показан за първична и бустер ваксинация на кърмачета срещу дифтерия, тетанус, коклюш, хепатит В и полиомиелит.

Janumet Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

janumet

merck sharp & dohme b.v. - ситаглиптин, метформин хидрохлорид - Захарен диабет тип 2 - Лекарства, използвани при диабет - За пациенти със захарен диабет тип 2:janumet е показан като допълнение към диетата и физическите упражнения за подобряване на гликемичния контрол при пациенти, недостатъчно контролирани за тяхното максимално переносимой доза само метформина или тези, които вече са подложени на лечение с комбинация от ситаглиптина и метформина. janumet е посочено в комбинация с сульфонилмочевины (аз. тройно комбинирано лечение) като допълнение към диета и упражнения при пациенти, недостатъчно контролирани за тяхното максимално переносимой дозата на метформина и сульфонилмочевины. janumet е посочено като тройна комбинирана терапия с агонист Рап (аз. , тиазолидиндионом) като допълнение към диета и упражнения при пациенти, недостатъчно контролирани за тяхното максимално переносимой дозата на метформина и НПСР агонист. janumet също така е показано, като добавите към инсулин (аз. тройно комбинирано лечение) като допълнение към диета и физически упражнения за подобряване на гликемичния контрол при пациенти, при стабилна доза на инсулина и метформина сам не осигуряват адекватен гликемичен контрол.

Sorbisterit 15 g powder for oral/rectal suspension in sachet Bulgarija - bulgarų - Изпълнителна агенция по лекарствата

sorbisterit 15 g powder for oral/rectal suspension in sachet

fresenius medical care nephrologica deutschland gmbh - 15 g powder for oral/rectal suspension in sachet

Anapen 300 micrograms /0,3 ml solution for injection, pre - filled siringe Bulgarija - bulgarų - Изпълнителна агенция по лекарствата

anapen 300 micrograms /0,3 ml solution for injection, pre - filled siringe

lincoln medical limited - Эпинефрин - 300 micrograms /0,3 ml solution for injection, pre - filled siringe

Techescan Sestamibi 1 mg kit for radiopharceutical preparation Bulgarija - bulgarų - Изпълнителна агенция по лекарствата

techescan sestamibi 1 mg kit for radiopharceutical preparation

mallinkrodt medical b.v. - Технеция (99мтс) sestamibi - 1 mg kit for radiopharceutical preparation