Европска Унија - Естонски - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosupressandid - palun vaadake jaotist 4. tooteteabe omaduste kokkuvõtte 1. osa tooteinfo dokumendis.

Европска Унија - Естонски - EMA (European Medicines Agency)

novartis europharm ltd. - aliskireen - hüpertensioon - reniini-angiotensiini süsteemi toimivad ained - essentsiaalse hüpertensiooni ravi.

Европска Унија - Естонски - EMA (European Medicines Agency)

adienne s.r.l. s.u. - tiotepa - hematopoeetiline tüvirakkude siirdamine - antineoplastilised ained - kombineerimine teiste kemoteraapia ravimeid:koos või ilma kogu keha kiiritamist (tbi), nagu konditsioneer ravi enne allogeensete või autoloogse vereloome tüvirakkude siirdamist (hpct) hematoloogilised haigused täiskasvanud ja pediaatriliste patsientide;kui suure annusega keemiaravi koos hpct toetus on asjakohane ravi tahkete kasvajate täiskasvanud ja pediaatriliste patsientide. see on ettepanek, et tepadina peab olema ette nähtud arstid kogenud konditsioneerimine ravi enne vereloome tüvirakkude siirdamine.

Европска Унија - Естонски - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, hepatitis b surface antigen, bordetella pertussis (inactivated), tetanus toxoid - hepatitis b; tetanus; immunization; whooping cough; diphtheria - vaktsiinid - tritanrix hepb on näidustatud aktiivseks vaktsineerimiseks difteeria, teetanuse, läkaköha ja hepatiit b (hbv) vastu kuue nädala vanustel lastel (vt lõik 4.

Европска Унија - Естонски - EMA (European Medicines Agency)

bayer ag - rivaroksabaan - arthroplasty, replacement; venous thromboembolism - antitrombootilised ained - xarelto, co-manustada atsetüülsalitsüülhape (asa) üksi või koos asa pluss clopidogrel või ticlopidine, on näidustatud ennetamine atherothrombotic sündmuste täiskasvanud patsientidel pärast äge koronaarsündroom (acs) kõrgenenud südame biomarkerite. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. täiskasvanud patsientidel, kellele tehti plaaniline puusa- või põlveliigese asendamise operatsiooni venoosse trombemboolia (vte) ennetamine. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Европска Унија - Естонски - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituksimab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastilised ained - rituzena on näidatud täiskasvanute jaoks järgmisi andmeid:mitte-hodgkini lümfoom (nhl)rituzena on näidustatud raviks eelnevalt ravimata patsientidel iii etapp iv follikulaarne lümfoom kombinatsioonis keemiaraviga. rituzena monotherapy on näidustatud patsientidele, kellel iii etapp iv follikulaarne lümfoom, kes on kemo vastupidavad või on oma teine või järgmine hakkavad pärast keemiaravi. rituzena on näidustatud patsientide raviks cd20 positiivne hajus suur b-rakkude mitte hodgkini lümfoom koos karbonaad (tsüklofosfamiid, doxorubicin, vincristine, prednisoloon) keemiaravi. krooniline lümfoidne leukeemia (cll)rituzena kombinatsioonis keemiaraviga on näidustatud patsientide raviks eelnevalt ravimata ja taastekkinud/tulekindlad cll. ainult piiratud andmed on saadaval efektiivsust ja ohutust patsientidel, eelnevalt ravitud monoklonaalsete antikehadega (sealhulgas rituzenaor patsientidel, tulekindlad, et eelmise rituzena pluss kemoteraapiat. granulomatosis koos polyangiitis ja mikroskoopilised polyangiitisrituzena, koos glucocorticoids, on näidustatud remissiooni induktsioon täiskasvanud patsientidel, kellel on raske, aktiivse granulomatosis koos polyangiitis (wegener) (gpa) ja mikroskoopilised polyangiitis (mpa).

Европска Унија - Естонски - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - neutropeenia - immunostimulants, - vähendada kestus neutropenia ja esinemissagedus febriilsed neutropenia tõttu keemiaravi.

Европска Унија - Естонски - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuuria, paroksüsmaalne - selektiivsed immunosupressandid - 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.

Европска Унија - Естонски - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - antineoplastilised ained - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Европска Унија - Естонски - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastilised ained - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).