Bulgarije - Bulgaars - Изпълнителна агенция по лекарствата

astrazeneca pharmaceuticals ab - Гозерелин - 10,8 mg implant

Bulgarije - Bulgaars - Изпълнителна агенция по лекарствата

astrazeneca ab - 500 mg/20 mg modified-release tablets

Bulgarije - Bulgaars - Изпълнителна агенция по лекарствата

astrazeneca ab - Фелодипин - 5 mg prolonged - release tablets

Bulgarije - Bulgaars - Изпълнителна агенция по лекарствата

astrazeneca ab - Езомепразол - 40 mg powder for solution for injection/infusion

Europese Unie - Bulgaars - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - Карцином, недребноклетъчен белодроб - Антинеопластични средства - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Europese Unie - Bulgaars - EMA (European Medicines Agency)

astrazeneca ab - метформина хидрохлорид, Саксаглиптин, dapagliflozin - Захарен диабет тип 2 - Лекарства, използвани при диабет - qtrilmet е показан при възрастни на възраст 18 и повече години с диабет тип 2, за подобряване на гликемичния контрол при метформином или без сульфонилмочевины (Су) и саксаглиптин или dapagliflozin не осигурява адекватен гликемичен контрол . когато вече лекувани с метформин и саксаглиптин и dapagliflozin.

Europese Unie - Bulgaars - EMA (European Medicines Agency)

alexion europe sas - себелапаза алфа - Липиден метаболизъм, вродени грешки - Други стомашно-чревния тракт и обмяната на веществата средства, - kanuma е показан за дългосрочна ензимна заместителна терапия (ert) при пациенти на всички възрасти с дефицит на лизозомална киселина липаза (lal).

Europese Unie - Bulgaars - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - Хемоглобинурия, пароксизма - Селективни имуносупресори - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Europese Unie - Bulgaars - 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.

Europese Unie - Bulgaars - EMA (European Medicines Agency)

alexion europe sas - Экулизумаб - Хемоглобинурия, пароксизма - Имуносупресори - Солирис е показан за възрастни и деца за лечение на:пароксизмальная нощен гемоглобинурия (АСИСТЕНЦИИ). Доказателства клиничен ефект се проявява при пациенти с гемолизом с клиничен симптом(и) свидетелства за висока активност на заболяването, независимо от историята на преливане (виж раздел 5. Атипичный гемолитико-уремический (Агус). Солирис е показан при възрастни за лечение на:огнеупорни генерализирана миастенией Гравис (ГГМ) при пациенти с анти-ацетилхолиновому рецепторите (АЧР) антитела (виж раздел 5. Разстройство neuromyelitis на зрителния спектър (nmosd) при пациенти, които са анти-aquaporin-4 (aqp4) антитела с рецидивирующим течение на заболяването.