Европейски съюз - български - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - грипен вирус повърхностните антигени (хемаглутинин и невраминидазния) на щам a/Виетнам/1194/2004 (Н5n1) - influenza, human; immunization; disease outbreaks - Ваксини - Активна имунизация срещу подтип h5n1 на вируса на грипа А. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Европейски съюз - български - EMA (European Medicines Agency)

sanofi b.v. - севеламер - renal dialysis; hyperphosphatemia - Всички други терапевтични продукти - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - Антибактериални средства за подаване на заявления, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти. правилното използване на антибактериални средства.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - fosamil цефтаролин - community-acquired infections; skin diseases, infectious; pneumonia - Антибактериални средства за подаване на заявления, - zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: , complicated skin and soft tissue infections (cssti), community-acquired pneumonia (cap) , consideration should be given to official guidance on the appropriate use of antibacterial agents.

Европейски съюз - български - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, кобицистат, emtricitabine, tenofovir alafenamide - ХИВ инфекции - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza е показан за лечение на човешкия имунодефицитен вирус тип 1 инфекция (hiv‑1) при възрастни и юноши (на възраст 12 години и повече с тяло тегло поне 40 кг). genotypic testing should guide the use of symtuza.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - Антинеопластични средства - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq като монотерапии е предназначен за лечение на възрастни пациенти с локално-напреднал или метастазирал НМРЛ след като по-рано химиотерапия. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq като монотерапии е предназначен за лечение на възрастни пациенти с локално-напреднал или метастазирал НМРЛ след като по-рано химиотерапия. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Европейски съюз - български - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - Неоплазми на гърдата - Антинеопластични средства - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - Неоплазми на гърдата - Антинеопластични средства - talzenna включен като монотерапии за лечение на възрастни пациенти с зародышевой линия на гените brca1/2 мутации, които са her2-отрицателен локално-разпространена или метастатичен рак на гърдата . patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Пациентите с рецептор хормон (ч)-положителен рак на гърдата трябва да бъдат обработени до ендокринно-терапия, или да се считат за неподходящи за ендокринна терапия на базата на.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - трастузумаб - breast neoplasms; stomach neoplasms - Антинеопластични средства - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Преди химиотерапията трябва да бъдат включени най-малко антрациклина и таксана, ако пациентите не са подходящи за тези процедури. Хормон-рецептор-позитивни пациенти, също трябва да бъде не на хормоналната терапия, ако пациентите не са подходящи за тези процедури.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. в комбинация с доцетакселом за лечение на пациенти, които не са получавали химиотерапия за метастатичен болест. в комбинация с инхибитор на ароматаза инхибитори за лечение на пациенти след менопауза с хормон-рецептор позитивен ГБЦ, не по-рано от получаващи трастузумаб. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). след операция, химиотерапия (неоадъювантной или помощните) и лъчетерапия (ако е приложимо). след помощните химиотерапия с доксорубицином и циклофосфамидом, в съчетание с паклитакселом или доцетакселом. в комбинация с помощните химиотерапия, състояща се от доцетаксела и карбоплатина. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. Трябва да се използват точни и доказани методи за анализ .

Европейски съюз - български - EMA (European Medicines Agency)

d&a pharma - натриев оксибат - substance withdrawal syndrome; alcohol abstinence - Други лекарства в нервната система - substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.