Unione Europea -
bulgaro -
EMA (European Medicines Agency)
rozlytrek
roche registration gmbh - entrectinib - cancer; carcinoma, non-small-cell lung - Антинеопластични средства - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.
Unione Europea -
bulgaro -
EMA (European Medicines Agency)
calquence
astrazeneca ab - acalabrutinib - Левкемия, лимфоцитна, хронична, В-клетка - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.
Unione Europea -
bulgaro -
EMA (European Medicines Agency)
lumoxiti
astrazeneca ab - moxetumomab pasudotox - Левкемия, космат килия - Антинеопластични средства - lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (hcl) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (pna).
Unione Europea -
bulgaro -
EMA (European Medicines Agency)
bylvay
albireo - odevixibat - cholestasis, intrahepatic - Болест и чернодробна терапия - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 и 5.
Bulgaria -
bulgaro -
БАБХ (Българска агенция по безопасност на храните)
doraxx 100 mg/ml solution for injection for cattle, pigs and sheep 100 mg/ml
dopharma research b.v. - Тулатромицин - инжекционен разтвор - 100 mg/ml - говеда, овце, свине
Unione Europea -
bulgaro -
EMA (European Medicines Agency)
qinlock
deciphera pharmaceuticals (netherlands) b.v. - ripretinib - Стомашно-чревни стромални тумори - Антинеопластични средства - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.