Европейски съюз -
български -
EMA (European Medicines Agency)
vaniqa
almirall, s.a. - Эфлорнитин - хирзутизъм - Други дерматологични препарати - Лечение на хирзутизъм при жените.
Европейски съюз -
български -
EMA (European Medicines Agency)
rubraca
pharmaand gmbh - rucaparib camsylate - Овариални неоплазми - Антинеопластични средства - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca включен като монотерапии за лечение на възрастни пациенти с платиночувствительный е рецидив на високо качество на епитела на яйчниците, фалопиевите тръби или първичен перитонеальным рак, които в отговор (пълна или частична) на базата на платина химиотерапия.
Европейски съюз -
български -
EMA (European Medicines Agency)
imatinib koanaa
koanaa healthcare gmbh - иматиниба мезилат - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Антинеопластични средства - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. Пациентите, които имат нисък или много нисък риск от рецидив, не трябва да получават помощните терапия. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. С изключение първи път е идентифицирана хронична фаза на ХМЛ, няма контролирани проучвания, които показват клиничен ефект, или увеличава процента на преживяемост при тези заболявания.
Европейски съюз -
български -
EMA (European Medicines Agency)
nulibry
tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - Други стомашно-чревния тракт и обмяната на веществата средства, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.
Европейски съюз -
български -
EMA (European Medicines Agency)
nobilis ib primo qx
intervet international b.v. - жив птичи вирус на инфекциозен бронхит, щам d388 - live viral vaccines, domestic fowl - Пиле - За активна имунизация на пилета с цел намаляване на респираторните признаци на инфекциозен бронхит при птиците, причинени от qx-подобни варианти на вируса на инфекциозния бронхит.
България -
български -
БАБХ (Българска агенция по безопасност на храните)
comfortan 10 mg/ml solution for injection for dogs and cats 8.9 mg/ml
evrovet animal health b.v - Метадон - инжекционен разтвор - 8.9 mg/ml - котки, кучета