Nilemdo Europska Unija - hrvatski - EMA (European Medicines Agency)

nilemdo

daiichi sankyo europe gmbh - bempedoic kiseline - hypercholesterolemia; dyslipidemias - sredstva za modifikaciju lipida - nilemdo prikazan kod odraslih pacijenata s primarnim гиперхолестеринемии (гетерозиготная obiteljska i nije nasljedna) ili mješoviti dislipidemija kao dodatak prehrani u kombinaciji sa statinima ili statina s drugim гиполипидемической terapije kod bolesnika nisu uspjeli postići ldl s namjene s najviše переносимой doze statina (vidi 4. 2, 4. 3 i 4. 4) ili,zasebno ili u kombinaciji s drugim гиполипидемической terapije statinima u bolesnika нетолерантно, ili za koga statinima kontraindiciran.

Veklury Europska Unija - hrvatski - EMA (European Medicines Agency)

veklury

gilead sciences ireland uc - remdesivir - covid-19 virus infection - veklury is indicated for the treatment of coronavirus disease 2019 (covid 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

Nemdatine Europska Unija - hrvatski - EMA (European Medicines Agency)

nemdatine

actavis group ptc ehf. - memantin - alzheimerova bolest - psychoanaleptics i drugih anti-demencije lijekovi - liječenje bolesnika s umjerenom ili teškom alzheimerovom bolesti.

Comirnaty Europska Unija - hrvatski - EMA (European Medicines Agency)

comirnaty

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna 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 - cjepiva - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Zabdeno Europska Unija - hrvatski - EMA (European Medicines Agency)

zabdeno

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - Геморрагическая groznice ebole - cjepiva - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Kineret Europska Unija - hrvatski - EMA (European Medicines Agency)

kineret

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - imunosupresivi - reumatoidni artritis (ra)kinneret prikazan kod odraslih za liječenje znakova i simptoma ra u kombinaciji s metotreksatom, sa neadekvatno odgovorom na metotreksat samo . covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodična groznica syndromeskineret je indiciran za liječenje sljedećih аутовоспалительные sindromi periodična bolest kod odraslih, mlade, djecu i dojenčad u dobi od 8 mjeseci i stariji s tjelesnu masu od 10 kg i gore:криопиринассоциированные periodične sindromi (caps)s kinneret indiciran za liječenje poklopaca, uključujući:za novorođenčad-početak Мультисистемное upalna bolest (НОМИД) / kronični инфантильный neurološki, kožni, zglobne sindrom (Синка)Макла-wells sindrom (mw)obiteljska холодовая Аутовоспалительные sindrom (fcas)obiteljska mediteranska groznica (ФМФ)kinneret indiciran za liječenje obiteljska mediteranska groznica (ФМФ). kinneret mora se dati u kombinaciji s drugim lijekovima, ako je potrebno. još diseasekineret navodi u odrasle, mlade, djecu i dojenčad u dobi od 8 mjeseci i stariji s tjelesnu masu od 10 kg i gore za liječenje bolesti Стилла-Шоффара, uključujući i sistem juvenilni idiopatski artritis (sjia) i odrasloj dobi bolest Стилла-Шоффара (aop), s aktivnim sistemske funkcije umjerena do visoka aktivnost bolesti, ili kod pacijenata s trajna aktivnost bolesti nakon liječenja nesteroidni protuupalni lijekovi (nsar) i glukokortikoidi. kinneret može se dati u monoterapiji ili u kombinaciji s drugim anti-upalne lijekove i заболевани-razrađen antirheumatic napitke (dmards).

Airexar Spiromax Europska Unija - hrvatski - EMA (European Medicines Agency)

airexar spiromax

teva b.v. - сальметерол, flutikazon propionat - pulmonary disease, chronic obstructive; asthma - lijekovi za opstruktivne plućne bolesti dišnih putova, - airexar spiromax je indiciran za uporabu kod odraslih osoba u dobi od 18 i više godina. asthmaairexar spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist. kronične opstruktivne plućne bolesti (kopb)spiromax airexar indiciran za simptomatsko liječenje bolesnika s kopb s ОФВ1.

Cancidas (previously Caspofungin MSD) Europska Unija - hrvatski - EMA (European Medicines Agency)

cancidas (previously caspofungin msd)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Combivir Europska Unija - hrvatski - EMA (European Medicines Agency)

combivir

viiv healthcare bv - lamivudin, зидовудин - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - combivir is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection.

Dutrebis Europska Unija - hrvatski - EMA (European Medicines Agency)

dutrebis

merck sharp dohme limited - lamivudin, ралтегравир kalija - hiv infekcije - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis je indiciran u kombinaciji s drugim anti‑retroviral lijekovima za liječenje humane imunodeficijencije (hiv‑1) infekcija u odraslih, adolescenata i djece u dobi od 6 godina i tjelesne težine najmanje 30 kg bez sadašnjosti ili prošlosti dokaz virusne otpornosti na antivirusne lijekove institucije (rezistencije strand prijenos inhibitor) i eng. (inhibitor reverzne transkriptaze nukleozida) klase (vidjeti dio 4. 2, 4. 4 i 5.