Unione Europea - bulgaro - EMA (European Medicines Agency)

zoetis belgium sa - диботермин алфа - Костни морфогенни протеини - Кучета - Остеоиндуктивен агент за използване при лечението на фрактури на дълги кости като допълнение към стандартната хирургична намеса при използване на открито намаляване на фрактурата при кучета.

Bulgaria - bulgaro - Изпълнителна агенция по лекарствата

medac gesellschaft fur klinische spezialpraparate gmbh - 15000iu (30 000iv) (ph. eur.) powder for solution for injection

Unione Europea - bulgaro - EMA (European Medicines Agency)

the medicines company uk ltd - Бивалирудин - Остър коронарен синдром - Антитромботични агенти - angiox включен като антикоагуланти при възрастни пациенти, подложени на чрескожное коронарна интервенция (ЧКВ), включително и при пациенти с st-сегмента височина на инфаркт на миокарда (stemi) минавайки през първичния ЧКВ. angiox също така е показан за лечение на възрастни пациенти с нестабилна стенокардия / липса на сегмента st инфарктом на миокарда (eli / ОИМ без вдигане на st сегмент), планирани за спешно или ранна интервенция. angiox трябва да предпише аспирин и клопидогрел.

Unione Europea - bulgaro - EMA (European Medicines Agency)

intervet international bv - инактивиран цял антиген на вируса на инфлуенца по птиците от Н5 подтип (щам h5n6, a / duck / potsdam / 2243/84) - Имунологични за аве - Пиле - За активна имунизация на пилета срещу инфлуенца по птиците тип А, подтип h5. Намаляването на клиничните признаци, смъртността и екскрецията на вируса след предизвикване на вирулентен щам h5n1 се установяват до две седмици след еднократна ваксинация. Суроватъчните антитела, както е доказано, се запазва пилета най-малко 7 месеца и изследвания, проведени с други щамове, показват, че суроватъчните антитела ще се запази и кокошки, най-малко 12 месеца след въвеждането на две дози от ваксината.

Unione Europea - bulgaro - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - Стомашно-чревни стромални тумори - Други противоракови лекарства, инхибитори на протеинкиназы - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Unione Europea - bulgaro - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - Талидомид - Множествена миелома - Имуносупресори - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Unione Europea - bulgaro - EMA (European Medicines Agency)

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.

Unione Europea - bulgaro - EMA (European Medicines Agency)

juta pharma gmbh - пегфилграстин - Неутропения - Иммуностимуляторы, - Намаляване на продължителността на неутропения и честотата на фебрилна неутропения при възрастни пациенти, лекувани с цитотоксична химиотерапия за злокачествено заболяване (с изключение на хронична миелоидна левкемия и миелодиспластични синдроми).

Unione Europea - bulgaro - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol acetate, mometasone furoate - астма - Лекарства за обструктивна заболявания на дихателните пътища, - atectura breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Unione Europea - bulgaro - EMA (European Medicines Agency)

sanofi-aventis - римонабант - прекалена пълнота - Препарати против затлъстяване, с изключение на тези, диетични продукти - Като допълнение към диета и физически упражнения за лечение на пациенти с наднормено тегло (ИТМ от 30 кг/м2) или пациенти с наднормено тегло (ИТМ от 27 kg/m2) риск, свързан с фактор(ami), като тип 2 диабет или дислипидемии (виж раздел 5.