Clopidogrel BMS Европейски съюз - български - EMA (European Medicines Agency)

clopidogrel bms

bristol-myers squibb pharma eeig - clopidogrel (as hydrogen sulfate) - stroke; peripheral vascular diseases; myocardial infarction; acute coronary syndrome - Антитромботични агенти - Клопидогрел е показан за възрастни за профилактика на атеротромботических събития:- пациенти, страдащи от инфарктом инфаркт (от няколко дни до по-малко от 35 дни), исхемичен инсулт (от 7 дни до по-малко от 6 месеца) или установена заболяване на периферните артерии. - Пациенти, страдащи от остър коронарным синдром:без вдигане на сегмента st остър коронарный синдром (нестабилна стенокардия или не-q-инфарктом на миокарда), включително пациенти, подложени на поставянето на стента след чрескожного коронарна интервенция, в комбинация с ацетилсалицилова киселина (ask). Възхода на сегмента st остър инфаркт на миокарда, в комбинация с ВЪЗХОДЯЩО в лечението на пациенти, които имат право на тромболитической терапия.

Opdualag Европейски съюз - български - EMA (European Medicines Agency)

opdualag

bristol-myers squibb pharma eeig - nivolumab, relatlimab - Меланомът - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Bosulif Европейски съюз - български - EMA (European Medicines Agency)

bosulif

pfizer europe ma eeig - бозутиниб (като монохидрат) - Левкемия, миелоид - antineoplastic agents, protein kinase inhibitors - bosulif е показан за лечение на възрастни пациенти с идентифицирана за първи път хронична фаза (cp) на хромозомите-положителен Филаделфия хронична миелогенной левкемия (ph+ ХМЛ). СР, ускорена фаза (ap), и бластном (bp) ph+ ХМЛ, по-рано, на които един или повече инхибитори на тирозинкиназы(с) [tgc(И)] и за кого imatinib, nilotinib и dasatinib не се считат за подходящи възможности за лечение .

Zinforo Европейски съюз - български - EMA (European Medicines Agency)

zinforo

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.

Lorviqua Европейски съюз - български - EMA (European Medicines Agency)

lorviqua

pfizer europe ma eeig - lorlatinib - Карцином, недребноклетъчен белодроб - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Quofenix Европейски съюз - български - EMA (European Medicines Agency)

quofenix

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin меглюмина - Инфекции, придобити от общността - Антибактериални средства за подаване на заявления, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 и 5. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Spikevax (previously COVID-19 Vaccine Moderna) Европейски съюз - български - EMA (European Medicines Agency)

spikevax (previously covid-19 vaccine moderna)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - Ваксини - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Rekambys Европейски съюз - български - EMA (European Medicines Agency)

rekambys

janssen-cilag international nv - rilpivirine - ХИВ инфекции - Антивирусни средства за системно приложение - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

Nexpovio Европейски съюз - български - EMA (European Medicines Agency)

nexpovio

stemline therapeutics b.v. - selinexor - Множествена миелома - Антинеопластични средства - nexpovio is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Oxbryta Европейски съюз - български - EMA (European Medicines Agency)

oxbryta

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.