Uni Eropa - Malta - EMA (European Medicines Agency)

tillotts pharma gmbh - fidaxomicin - infezzjonijiet ta 'clostridium - antidiarrheals, intestinali anti-infjammatorji / antiinfective aġenti - dificlir pilloli miksija b'rita huwa indikat għall-kura ta clostridioides difficile infezzjonijiet (cdi) magħruf ukoll bħala c. difficile-assoċjat dijarea (cdad) f'pazjenti adulti u pedjatriċi b'piż tal-ġisem ta ' mill-inqas 12-il. 5 kg. konsiderazzjoni għandha tingħata sabiex il-linji gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi. dificlir granijiet għal suspensjoni orali huwa indikat għall-kura ta clostridioides difficile infezzjonijiet (cdi) magħruf ukoll bħala c. difficile-assoċjat dijarea (cdad) fl-adulti u f'pazjenti pedjatriċi mit-twelid sa < 18-il sena. konsiderazzjoni għandha tingħata sabiex il-linji gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Uni Eropa - Malta - 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. , , ,.

Uni Eropa - Malta - EMA (European Medicines Agency)

astellas pharma gmbh - tacrolimus - dermatite, atopika - preparazzjonijiet oħra dermatoloġiċi - kura ta 'dermatite atopika moderata għal severa f'adulti li ma jirrispondux b'mod adegwat għal jew mhumiex intolleranti għal terapiji konvenzjonali bħal kortikosterojdi topiċi. kura ta 'dermatite atopika moderata għal severa fit-tfal (ta' sentejn jew aktar) li naqset milli twieġeb b'mod adegwat għal terapiji konvenzjonali bħal kortikosterojdi topiċi. l-manteniment tat-trattament ta 'dermatite atopika moderata għal severa għall-prevenzjoni tal-flares u l-estensjoni tal-flare intervalli mingħajr f'pazjenti li qed jesperjenzaw il-frekwenza għolja ta' rkadar tal-marda (i. li jseħħu 4 darbiet jew aktar fis-sena) li kellhom rispons inizjali għal massimu ta '6 ġimgħat trattament ta' ingwent ta 'tacrolimus darbtejn kuljum (leżjonijiet approvati, kważi approvati jew affettwati b'mod ħafif).

Uni Eropa - Malta - EMA (European Medicines Agency)

midas pharma gmbh - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - oftalmoloġiċi - ranivisio is indicated in adults for:• the treatment of neovascular (wet) age-related macular degeneration (amd)• the treatment of visual impairment due to diabetic macular oedema (dme)• the treatment of proliferative diabetic retinopathy (pdr)• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)• the treatment of visual impairment due to choroidal neovascularisation (cnv).

Uni Eropa - Malta - EMA (European Medicines Agency)

teva pharma b.v.  - budesonide, formoterol fumarate dihydrate - asthma; pulmonary disease, chronic obstructive - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - budesonide / formoterol teva pharma b. hija indikata fl-adulti ta '18-il sena u akbar biss. asthmabudesonide/formoterol teva pharma b. huwa indikat fit-trattament regolari ta ' l-ażżma, fejn l-użu tal-kombinazzjoni (kortikosterojdi meħuda man-nifs u li jaħdem fit-tul β2 adrenoceptor agonist) huwa xieraq:-f'pazjenti li mhumiex adegwatament ikkontrollati bil-kortikosterojdi meħuda man-nifs u l - "kif meħtieġ" man-nifs qasir waqt li jaġixxi β2 adrenoceptor agonisti. jew f'pazjenti li diġà ikkontrollati adegwatament fuq iż-żewġ kortikosterojdi meħuda man-nifs u li jaħdem fit-tul β2 adrenoceptor agonisti. copdsymptomatic-trattament ta ' pazjenti b'copd mal-nifs sfurzat'il-volum fl-1 sekonda (fev1) .

Uni Eropa - Malta - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. f'pazjenti adulti, li jgħin biex jiddistingwi-probabbiltà ta ' dimenzja b'lewy bodies mill-marda ta'alzheimer.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

Uni Eropa - Malta - EMA (European Medicines Agency)

merz pharmaceuticals gmbh   - memantina idrokloridu - marda ta 'alzheimer - mediċini oħra kontra d-demenzja - trattament ta 'pazjenti b'mard ta' alzheimer moderat għal sever.

Uni Eropa - Malta - EMA (European Medicines Agency)

abz-pharma gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - fatturi li jistimulaw kolonji - biograstim huwa indikat għat-tnaqqis fid-dewmien ta 'newtropenja u l-inċidenza ta' newtropenja bid-deni f'pazjenti kkurati b'kimoterapija ċitotossika stabbilita għal malinn (bl-eċċezzjoni ta 'lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat-tnaqqis fid-dewmien ta' newtropenja f'pazjenti li jkollhom terapija majeloablattiva segwita mill-għadam-trapjant tal-mudullun kkunsidrati li jkunu f'riskju akbar fit-tul ta ' newtropenja severa. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. biograstim huwa indikat għall-mobilizzazzjoni tal-taċ-ċelluli proġenitriċi tad-demm periferali (pbpc). f'pazjenti, tfal jew adulti, b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' 0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti, l-għoti fit-tul b'biograstim huwa indikat biex jiżdied l-għadd ta'newtrofili u biex inaqqas l-inċidenza u t-tul ta ' l-infezzjoni avvenimenti relatati mal-. biograstim huwa indikat għall-kura ta 'newtropenja persistenti (anc ta' inqas minn jew ugwali għal 1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

Uni Eropa - Malta - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - edoxaban tosilate - stroke; venous thromboembolism - aġenti antitrombotiċi - prevenzjoni ta ' stroke u moћћ sistematiku fil-pazjenti adulti bl-fibrillation atrial nonvalvular (nvaf) b ' waħda jew aktar fatturi tar-riskju, bħal konġestiva, ipertensjoni, età ≥ 75 sena, id-diabete mellitus, stroke minn qabel jew ischaemic għaddiena attakk) tia). trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti.

Uni Eropa - Malta - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - irbesartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. din id-doża fissa kombinata hija indikata f'pazjenti adulti li l-pressjoni tad-demm ma tkunx ikkontrollata adegwatament fuq irbesartan jew b ' hydrochlorothiazide waħidhom (ara sezzjoni 5.