Unjoni Ewropea - Malti - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - aġenti antitrombotiċi - , , , , 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. , , ,.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - duoplavin huwa indikat għall-prevenzjoni sekondarja ta 'avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qegħdin jieħdu clopidogrel u acetylsalicylic acid (asa). duoplavin is a fixed-dose combination medicinal product for continuation of therapy in: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 (pci);st segment elevation acute myocardial infarction (stemi) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - newtropenja - immunostimulanti, , l-fatturi li jistimulaw kolonji - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel hydrogen sulfate - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - aġenti antitrombotiċi - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic 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. il-prevenzjoni ta aterotrombotiċi u avvenimenti tromboemboliċi fil-fibrillazzjoni ta 'l-fibrillationin pazjenti adulti li jbatu minn fibrillazzjoni atrijali li jkollhom mill-inqas fattur ta' riskju wieħed għall-episodji vaskulari, mhumiex adattati għall-kura bil-vitamina k antagonisti u li għandhom baxx-riskju ta'fsada, clopidogrel huwa indikat, flimkien ma ' asa għall-prevenzjoni tal-aterotrombotiċi u avvenimenti tromboemboliċi, inkluż puplesija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - follitropin delta - anovulazzjoni - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - kkontrollati stimulazzjoni ovarjan għall-iżvilupp ta ' sejbien multipli fin-nisa ċiklu li qegħdin isirulhom assistit riproduttivi teknoloġiji (l-arti) bħal fertilizzazzjoni in vitro (ivf) jew injezzjoni ta ' l-isperma intracytoplasmic (icsi).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto - pramipexole dihydrochloride monohydrate - marda ta 'parkinson - mediċini kontra l-parkinson - oprymea hija indikata għat-trattament tas-sinjali u s-sintomi tal-marda ta 'parkinson idjopatika, waħedha (mingħajr levodopa) jew flimkien ma' levodopa, i. matul il-kors tal-marda, permezz ta'l-aħħar stadji meta l-effett ta ' levodopa jonqos ħafna jew isir inkonsistenti u l-varjazzjonijiet tal-effett terapewtiku jseħħu (fl-aħħar tad-doża jew "on off" varjazzjonijiet). oprymea huwa indikat fl-adulti għall-kura sintomatika ta moderata għal severa idjopatika tal-sindromu ta ' restless legs f'dożi sa 0. 54 mg ta ' bażi (0. 75 mg ta ' melħ) (ara sezzjoni 4.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - tocilizumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; cytokine release syndrome; giant cell arteritis; covid-19 virus infection - immunosoppressanti - roactemra, f'taħlita ma ' methotrexate (mtx), huwa indikat għall-kura ta attiva u progressiva severa, artrite rewmatojde (ra) fl-adulti li ma kienux ittrattati qabel b'mtx. il-kura moderata għal severa u attiva f'pazjenti adulti li jkollhom jew wieġbu b'mod inadegwat għal, jew li kienu intolleranti għal, it-terapija preċedenti b'wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards) jew tal-fattur ta'nekrożi tumorali (tnf) antagonisti. f'dawn il-pazjenti, roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika meta jingħata flimkien ma ' methotrexate. roactemra huwa indikat għall-kura ta attiva sistemika, artrite idjopatika ġuvenili (sjia) fil-pazjenti li 1-età ta'sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma ' nsaids u kortikosterojdi sistemiċi. roactemra jista 'jingħata bħala monoterapija (fil-każ ta' intolleranza għal mtx jew fejn kura b'mtx mhux xierqa) jew flimkien ma ' mtx. roactemra flimkien ma 'methotrexate (mtx), huwa indikat għall-kura ta idjopatika ġuvenili polijartrite (pjia; rewmatika fattur pożittiv jew negattiv u estiż oligoarthritis) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra huwa indikat għall-kura tal-Ġgant taċ-Ċelluli artrite (gca) f'pazjenti adulti. roactemra, f'taħlita ma ' methotrexate (mtx), huwa indikat għall -: - trattament ta attiva u progressiva severa, artrite rewmatojde (ra) fl-adulti li ma kienux ittrattati qabel b'mtx. il-kura moderata għal severa u attiva f'pazjenti adulti li jkollhom jew wieġbu b'mod inadegwat għal, jew li kienu intolleranti għal, it-terapija preċedenti b'wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards) jew tal-fattur ta'nekrożi tumorali (tnf) antagonisti. f'dawn il-pazjenti, roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra huwa indikat għall-kura ta attiva sistemika, artrite idjopatika ġuvenili (sjia) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma ' nsaids u kortikosterojdi sistemiċi. roactemra jista 'jingħata bħala monoterapija (fil-każ ta' intolleranza għal mtx jew fejn kura b'mtx mhux xierqa) jew flimkien ma ' mtx. roactemra flimkien ma 'methotrexate (mtx), huwa indikat għall-kura ta idjopatika ġuvenili polijartrite (pjia; rewmatika fattur pożittiv jew negattiv u estiż oligoarthritis) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra huwa indikat għall-kura ta kimeriku tal-antiġen tar-riċettur (karozza) taċ-ċelluli t-indotta severi jew li jipperikolaw il-ħajja-reħa taċ-ċitokina sindromu (crs) fl-adulti u pazjenti pedjatriċi minn 2 snin ta ' età u anzjani. roactemra, f'taħlita ma ' methotrexate (mtx), huwa indikat għall -: - trattament ta attiva u progressiva severa, artrite rewmatojde (ra) fl-adulti li ma kienux ittrattati qabel b'mtx. il-kura moderata għal severa u attiva f'pazjenti adulti li jkollhom jew wieġbu b'mod inadegwat għal, jew li kienu intolleranti għal, it-terapija preċedenti b'wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards) jew tal-fattur ta'nekrożi tumorali (tnf) antagonisti. f'dawn il-pazjenti, roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra huwa indikat għall-kura ta attiva sistemika, artrite idjopatika ġuvenili (sjia) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma ' nsaids u kortikosterojdi sistemiċi. roactemra jista 'jingħata bħala monoterapija (fil-każ ta' intolleranza għal mtx jew fejn kura b'mtx mhux xierqa) jew flimkien ma ' mtx. roactemra flimkien ma 'methotrexate (mtx), huwa indikat għall-kura ta idjopatika ġuvenili polijartrite (pjia; rewmatika fattur pożittiv jew negattiv u estiż oligoarthritis) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra huwa indikat għall-kura ta kimeriku tal-antiġen tar-riċettur (karozza) taċ-ċelluli t-indotta severi jew li jipperikolaw il-ħajja-reħa taċ-ċitokina sindromu (crs) fl-adulti u pazjenti pedjatriċi minn 2 snin ta ' età u anzjani.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - antiepilletiċi oħra - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrheals, intestinali anti-infjammatorji / antiinfective aġenti - truberzi huwa indikat fl-adulti għat-trattament tas-sindromu tal-musrana irritabbli bid-dijarea (ibs d).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eisai gmbh - alitretinoin - sarcoma, kaposi - aġenti antineoplastiċi - panretin gel hija indikata għat-trattament topiku ta ' leżjonijiet fil-ġilda f'pazjenti b'akkwistat-immuni-defiċjenza tal-syndrome (aids) relatati mal-sarkoma ta'kaposi (ks) meta: - leżjonijiet ma jkunux ulcerated jew lymphoedematous, u;it-trattament tal-vixxri ks ma hija meħtieġa, u; - leżjonijiet huma li ma jkunux qed jirrispondu għal sistemika-terapija kombinata antiretrovirali, u;ir-radjuterapija jew kimoterapija mhumiex xierqa.