Bulgaria - Bulgaria - БАБХ (Българска агенция по безопасност на храните)

Сева Анимал Хелт България ЕООД - live attenuated ibd virus, serotype 1, strain g-61 (winterfield 2512) - инжекционна суспензия - 0.7 – 2.7 log10 cid50 - пилета

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

csl behring gmbh - човешки нормален имуноглобулин (scig) - Синдроми на имунологична недостатъчност - Имунни серуми и имуноглобулини - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - Прекурсорна клетъчна лимфобластна левкемия-лимфом - Антинеопластични средства - besponsa включен като монотерапии за лечение на възрастни пациенти с пристъпно или продължителна cd22-положителни клетки b предшественици остра лимфоцитна левкемия (всички). При възрастни пациенти с положителна Филадельфийской хромозомата в яйцеклетката (рН+) повтарящите се или продължителна клетки предшественици следва този на изкуството на боравене с минимум 1 инхибитор на тирозинкиназы (cti).

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

pfizer europe ma eeig - гемтузумаб озогамицин - Левкемия, миелоиден, остър - Антинеопластични средства - mylotarg е показан за комбинирано лечение с даунорубицин (ДНР) и цитарабина (wac) за лечение на пациенти на възраст 15 и повече години по-рано с непреработени, де Ново cd33-положителни остър миелоидного левкемия (ОМЛ), с изключение на остър промиелоцитарного левкемия (опл).

Bulgaria - Bulgaria - БАБХ (Българска агенция по безопасност на храните)

ceva sante animale - Вирус е инфекциозно бурсальной болест (ibdv), прецедете winterfiled 2512 - лиофилизат и разтворител за инжекционна суспензия - най-малко 0,1 cid50 - бройлери, кокошки

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - Имуносупресори - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) е показан за лечение на възрастни пациенти с по-рано нелекувана множествена миеломой, на които не се разчита за трансплантация. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) е показан за лечение на възрастни пациенти с по-рано нелекувана множествена миеломой, на които не се разчита за трансплантация. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - Имуносупресори - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) е показан за лечение на възрастни пациенти с по-рано нелекувана множествена миеломой, на които не се разчита за трансплантация. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 и 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) е показан за лечение на възрастни пациенти с по-рано нелекувана множествена миеломой, на които не се разчита за трансплантация. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 и 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - Неоплазми на гърдата - Антинеопластични средства - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - Антинеопластични средства - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Kesatuan Eropah - Bulgaria - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - Лупус еритематозус, системен - Имуносупресори - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.