Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - drugi antineoplastiki - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedem, dedno - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - antitrombotična sredstva - prasugrel mylan, co daje z acetilsalicilne kisline (asa), je označen za preprečevanje atherothrombotic dogodkov pri odraslih bolnikih s akutni koronarni sindrom (i. nestabilna angina pektoris, ki niso-st segmentu višinskih miokardni infarkt [ua/nstemi] ali st segmentu višinskih miokardni infarkt [stemi]) v procesu primarne zamudo ali perkutani koronarni intervenciji (pci).

Evropska unija - slovenščina - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskularna blokada - vsi drugi terapevtski izdelki - zavrnitev nevromuskularne blokade, ki jo inducira rocuronium ali vecuronium. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Evropska unija - slovenščina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - gvanfacinijev klorid - motnja deficita pri hiperaktivnosti - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv mora biti uporabljena kot del celovite adhd zdravljenje programa, običajno vključujejo tudi psihološke, izobraževalnih in socialnih ukrepov.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - karcinom, pljučni pljuč - antineoplastic agents, protein kinase inhibitors - gefitinib mylan je označen kot monotherapy za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim non‑small cell lung cancer (nsclc) z aktiviranjem mutacije z egfr‑tk.

Evropska unija - slovenščina - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hidroklorid - vomiting; neoplasms; nausea; cancer - antiemetics in antinauseants, - akynzeo je navedeno v odraslim za:preprečevanje akutne in zapoznele slabost in bruhanja, povezanih z močno emetogenic cisplatin, ki temelji kemoterapijo raka. preprečevanje akutne in zapoznele slabost in bruhanja, povezanih z zmerno emetogenic kemoterapijo raka.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - okužbe z virusom hiv - antivirusi za sistemsko uporabo - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5. emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4. 2, 4. 4 in 5. pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4. 2, 4. 4 in 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - ceftaroline fosamil - community-acquired infections; skin diseases, infectious; pneumonia - antibacterials za sistemsko uporabo, - 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.