Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter plc. - улипристалов ацетат - Лейомиома - Полови хормони и слиза на половата система, - ulipristal acetate е посочена за един курс на лечение предоперационного лечение на умерени до тежки симптоми на миома на матката при жени в репродуктивна възраст. ulipristal acetate е показан при интермитентно лечение в среднетяжелых и тежки симптоми на миома на матката при жени в репродуктивна възраст, които не са допустими за операция.

Европейски съюз - български - EMA (European Medicines Agency)

chemical works of gedeon richter plc. (gedeon richter plc.) - ganirelix acetate - reproductive techniques, assisted; ovulation induction; infertility, female - Хипофизни и хипоталамични хормони и аналози - prevention of premature luteinising hormone (lh) surges in women undergoing controlled ovarian hyperstimulation (coh) for assisted reproduction techniques (art).

България - български - Изпълнителна агенция по лекарствата

leaves dry extract sanofi syrup

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.

България - български - БАБХ (Българска агенция по безопасност на храните)

Сева Анимал Хелт България ЕООД - Алфа-анатоксин ее. филтри от тип А, анатоксин ßeta ее.филтри тип С, Епсилон анатоксин ее. филтри тип Д,анатоксин ее.нов тип В /cl.oedematiens/, анатоксин ее.septicum, анатоксин ее. tetani,anaculture ее.chauvoei - инжекционна суспензия - ≥ 2, 0 iu/ml, ≥ 10, 0 iu/ml, ≥ 5, 0 iu/ml, ≥ 3, 5 iu/ml, ≥ 2, 5 iu/ml, ≥ 2, 5 iu/ml, 90 % защита - говеда, кози, овце

Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter - карипразин хидрохлорид - шизофрения - психолептици - reagila е показан за лечение на шизофрения при възрастни пациенти.

Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter plc. - фолитропин алфа - Ановулация - Полови хормони и слиза на половата система, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. В клинични проучвания при тези пациенти са били идентифицирани ендогенен нивото на серумните нива на lh < 1. 2 iu / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter ltd  - улипристалов ацетат - Лейомиома - Полови хормони и слиза на половата система, - ulipristal ацетат е показан за предоперативно лечение на умерени до тежки симптоми на маточни фиброми при възрастни жени в репродуктивна възраст. ulipristal acetate е показан при интермитентно лечение на умерени до тежки симптоми на миома на матката при жени в репродуктивна възраст.

Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter plc. - терипаратид - Остеопорозата - Калциева хомеостаза - terrosa е показан при възрастни. Лечение на остеопороза при жени в постменопауза и при мъже с повишен риск от фрактури. Жени в постменопауза е доказано значително намаляване на честотата на гръбначния и без вертебрални фрактури, но не фрактури. Лечение на остеопороза, свързан с постоянна и системна терапия глюкокортикоидами, при жените и мъжете при повишен риск от фрактури.

Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - Лейомиома - Хипофизни и хипоталамични хормони и аналози - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.