Atriance Evropska unija - slovenščina - EMA (European Medicines Agency)

atriance

sandoz pharmaceuticals d.d. - nelarabin - predkroglomerna limfoma t-celična limfoblastna levkemija - antineoplastična sredstva - nelarabine je indiciran za zdravljenje bolnikov z t-celic acute lymphoblastic levkemijo (t-all) in t-celic lymphoblastic limfom (t-lbl), katerih bolezen ni odgovorila, ali je relapsed po zdravljenju z vsaj dvema kemoterapijo regimens. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Evropska unija - slovenščina - EMA (European Medicines Agency)

clopidogrel taw pharma (previously clopidogrel mylan)

taw pharma (ireland) limited - klopidogrel hidroklorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotična sredstva - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. , - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). ,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

VidPrevtyn Beta Evropska unija - slovenščina - EMA (European Medicines Agency)

vidprevtyn beta

sanofi pasteur - sars-cov-2 prefusion spike delta tm protein, recombinant (b.1.351 strain) - covid-19 virus infection - cepiva - vidprevtyn beta is indicated as a booster for active immunisation to prevent covid-19 in adults who have previously received an mrna or adenoviral vector covid-19 vaccine (see sections 4. 2 in 5. 1 in product information document). uporaba tega cepiva mora biti v skladu z uradnimi priporočili.

Libmeldy Evropska unija - slovenščina - EMA (European Medicines Agency)

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - druga zdravila na živčnem sistemu - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Angiox Evropska unija - slovenščina - EMA (European Medicines Agency)

angiox

the medicines company uk ltd - bivalirudin - akutni koronarni sindrom - antitrombotična sredstva - angiox je indiciran kot antikoagulant pri odraslih bolnikih s perkutano koronarnim posegom (pci), vključno z bolniki z miokardnim infarktom elevacije st (stemi), ki se podvrže primarni pci. angiox je prikazano tudi za zdravljenje odraslih bolnikov z nestabilno angino pektoris / non-st-segmenta,-dvig miokardni infarkt (ua / nstemi) načrtovana za nujne ali zgodnje intervencije. angiox je treba dajati z aspirinom in clopidogrel.

Ontilyv Evropska unija - slovenščina - EMA (European Medicines Agency)

ontilyv

bial portela & companhia s.a. - opikapon - parkinsonova bolezen - anti-parkinsonska zdravila - ontilyv is indicated as adjunctive therapy to preparations of levodopa/ dopa decarboxylase inhibitors (ddci) in adult patients with parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Ionsys Evropska unija - slovenščina - EMA (European Medicines Agency)

ionsys

incline therapeutics europe ltd - fentanil hidroklorid - bolečina, postoperativna - analgetiki - zdravilo ionsys je indicirano za zdravljenje akutne zmerne do hude postoperativne bolečine pri odraslih bolnikih.

Xydalba Evropska unija - slovenščina - EMA (European Medicines Agency)

xydalba

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibacterials za sistemsko uporabo, - zdravljenje, akutna bakterijska kože in strukturo kožo okužb (absssi) pri odraslih.

Clopidogrel HCS Evropska unija - slovenščina - EMA (European Medicines Agency)

clopidogrel hcs

hcs bvba  - clopidogrel (as hydrochloride) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antitrombotična sredstva - sekundarno preprečevanje atherothrombotic eventsclopidogrel je navedeno v:izobraževanje odraslih bolnikih, ki trpijo za miokardni infarkt (od nekaj dni do manj kot 35 dni), ischaemic kap (od 7 dni do manj kot 6 mesecev) ali sedež periferne arterijske bolezni. za odrasle bolnike, ki trpijo za akutni koronarni sindrom:non-st segmentu višinskih akutni koronarni sindrom (nestabilna angina pektoris ali ne-q-val, miokardni infarkt), vključno z bolniki, ki opravljajo stent umestitev po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilne kisline (asa). st segmentu višinskih akutni miokardni infarkt, v kombinaciji s asa v medicinsko zdravljenih bolnikih, ki izpolnjujejo pogoje za thrombolytic terapija. preprečevanje atherothrombotic in thromboembolic dogodkov v atrijska fibrillationin odraslih bolnikov z atrijsko fibrilacijo, ki imajo vsaj en dejavnik tveganja za žilne dogodke, niso primerni za zdravljenje z antagonisti vitamina k (vka) in ki imajo nizko tveganje krvavitve, clopidogrel je indiciran v kombinaciji s asa za preprečevanje atherothrombotic in thromboembolic dogodkov, vključno z možgansko kap.  for further information please refer to section 5.