Byfavo European Union - Bulgarian - EMA (European Medicines Agency)

byfavo

paion deutschland gmbh - remimazolam besilate - Съзнателно седация - психолептици - remimazolam is indicated in adults for procedural sedation. remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.

Pylclari European Union - Bulgarian - EMA (European Medicines Agency)

pylclari

curium pet france - piflufolastat (18f) - Простатни неоплазми - Диагностични радиофармацевтици - Този лекарствен продукт е само за диагностична употреба. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Trecondi European Union - Bulgarian - EMA (European Medicines Agency)

trecondi

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - Трансплантация на хематопоетични стволови клетки - Антинеопластични средства - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Bondronat European Union - Bulgarian - EMA (European Medicines Agency)

bondronat

atnahs pharma netherlands b.v. - ибандронова киселина - hypercalcemia; breast neoplasms; neoplasm metastasis; fractures, bone - Лекарства за лечение на костни заболявания - Бондронат показан при:профилактика на скелетни събития (патологични фрактури, усложнения на костната тъкан, изискващи лъчетерапия или хирургическа намеса) при пациенти с рак на млечната жлеза и костни метастази;лечение на тумор-индуцирана гиперкальциемии С или без метастази.

Vegzelma European Union - Bulgarian - EMA (European Medicines Agency)

vegzelma

celltrion healthcare hungary kft. - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Антинеопластични средства - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Humira European Union - Bulgarian - EMA (European Medicines Agency)

humira

abbvie deutschland gmbh co. kg - адалимумаб - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - Имуносупресори - Моля, вижте документа с информация за продукта.

NovoRapid European Union - Bulgarian - EMA (European Medicines Agency)

novorapid

novo nordisk a/s - инсулин аспарт - Захарен диабет - Лекарства, използвани при диабет - novorapid е показан за лечение на захарен диабет при възрастни, юноши и деца на възраст над 1 година.

Ytracis European Union - Bulgarian - EMA (European Medicines Agency)

ytracis

cis bio international - 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. radiopharmaceutical precursor - not intended for direct application to patients.

Lutathera European Union - Bulgarian - EMA (European Medicines Agency)

lutathera

advanced accelerator applications - лутеций (177lu) оксодореотид - Невроендокринни тумори - Други терапевтични радиофармацевтици - lutathera е показан за лечение на неоперабилен или метастатичен рак, прогресивно, добре диференцирани (g1 и g2), соматостатин рецептор положителни gastroenteropancreatic невроендокринни тумори (gep‑nets) при възрастни.

LeukoScan European Union - Bulgarian - EMA (European Medicines Agency)

leukoscan

immunomedics gmbh - сулезомаб - osteomyelitis; radionuclide imaging - Диагностични агенти - Този лекарствен продукт е само за диагностична употреба. leukoscan е предназначен за диагностична визуализация за определяне на локализацията и разпространението на инфекция/възпаление на костите при пациенти с подозрение на остеомиелит, включително и при пациенти със синдром, диабет крак . leukoscan не се използват за диагностика на остеомиелит при пациенти със сърповидно-клетъчна анемия.