Teriflunomide Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

teriflunomide accord

accord healthcare s.l.u. - teriflunomide - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivima selektivni imunosupresivima - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Fingolimod Mylan Europska Unija - hrvatski - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - финголимод hidroklorid - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1)orpatients s brzo razvija težak relapsing ublažavanje multiplom sklerozom određuje se 2 ili više teških recidiva u roku od jedne godine, s 1 ili više gadolinij revitalizacije lezija na mr mozga ili značajno povećanje opterećenja t2 lezija u odnosu na najnoviji mri.

Fingolimod Mylan Europska Unija - hrvatski - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - финголимод hidroklorid - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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

vumerity

biogen netherlands b.v. - diroximel fumarate (biib098) - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Europska Unija - hrvatski - 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 - antitrombotska 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. , , ,.

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

tysabri

biogen netherlands b.v. - natalizumab - multipla skleroza - selektivni imunosupresivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 i 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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

tyruko

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 i 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

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

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - imuni serumi i homologna, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. pogledajte odjeljke 4. 4 i 5.

VidPrevtyn Beta Europska Unija - hrvatski - 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 - cjepiva - 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 i 5. 1 in product information document). korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

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

zontivity

merck sharp dohme limited - vorapaxar sulfat - infarkt miokarda - antitrombotska sredstva - zontivityis što je prikazano za smanjenje атеротромботических događaja u odraslih bolesnika s poviješću infarkta miokarda (im)su uvedeni u suradnji s ацетилсалициловой kiselina (asa) i, ako je potrebno, klopidogrel; ili - simptom bolesti perifernih arterija(зпа), koji je uveden u suradnji s ацетилсалициловой kiselinom (ask) ili, ako je potrebno, klopidogrel.