Paxene Европейски съюз - български - EMA (European Medicines Agency)

paxene

norton healthcare ltd. - паклитаксел - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - Антинеопластични средства - paxene е показан за лечение на пациенти с:• разширен, свързани със Спин сарком на Капоши (СПИН-ЧЕНГЕ), които не по-рано от липосомальных антрациклинов терапия;• метастатический рак на млечната жлеза (icb), които не са успели или не са кандидати за стандартни антрациклин-съдържаща терапия;• карцином на яйчника (aio) или с остатъчна болест (> 1 cm) след първична лапаротомии в комбинация с цисплатином на първа линия на лечение;• метастатический рак на яйчниците (mos), след неуспех platino-съдържаща комбинирана терапия без Таксанов като втора линия терапия;• немелкоклеточным рак на белия дроб (НМРЛ), които не са кандидати за потенциално лечебната хирургия и/или лъчетерапия в съчетание с цисплатином. Ограничените данни за ефикасността подкрепят това показание (вж. Раздел 5.

Beromun Европейски съюз - български - EMA (European Medicines Agency)

beromun

belpharma s.a. - тазонермин - саркома - Иммуностимуляторы, - beromun е показан при възрастни, като допълнение към операция за последващо отстраняване на тумора, така че да се предотврати или забави ампутирани, или палиативни ситуация, за нерезектабельных сарком на меките тъкани на крайниците, се използват в комбинация с мелфаланом чрез мек гипертермической изолирани крайници перфузия (ИЛП).

Ioa Европейски съюз - български - EMA (European Medicines Agency)

ioa

n.v. organon - nomegestrol ацетат, естрадиол - Контрацепция - Полови хормони и слиза на половата система, - Устна контрацепция.

Namuscla Европейски съюз - български - EMA (European Medicines Agency)

namuscla

lupin europe gmbh - mexiletine hydrochloride - Миотонических Нарушения - Сърдечна терапия - namuscla е показан за симптоматично лечение на миотонии при възрастни пациенти с не-дистрофические миотонических нарушения.

Amifampridine SERB Европейски съюз - български - EMA (European Medicines Agency)

amifampridine serb

serb sa - amifampridine phosphate - lambert-eaton myasthenic syndrome; paraneoplastic syndromes, nervous system; nervous system neoplasms; paraneoplastic syndromes; nervous system diseases; autoimmune diseases of the nervous system; neurodegenerative diseases; neuromuscular diseases; neuromuscular junction diseases; immune system diseases; autoimmune diseases; autoimmune diseases of the nervous system; cancer; neoplasms - Други лекарства в нервната система - Симптоматично лечение на миастенен синдром на lambert-eaton (lems) при възрастни.

Firdapse (previously Zenas) Европейски съюз - български - EMA (European Medicines Agency)

firdapse (previously zenas)

serb sa - амифампридинов - Миастеничен синдром на lambert-eaton - Други лекарства в нервната система - Симптоматично лечение на миастенен синдром на lambert-eaton (lems) при възрастни.

Opdivo Европейски съюз - български - 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.

Yttriga Европейски съюз - български - EMA (European Medicines Agency)

yttriga

eckert ziegler radiopharma gmbh - yttrium (90y) chloride - Радиоюклидно изображение - Диагностични радиофармацевтици - Да се ​​използва само за радиоизотопно маркиране на носителни молекули, които са специално разработени и разрешени за радиомаркиране с този радионуклид. Радиофармацевтический прекурсор - не е предназначен за директна употреба при пациенти.