Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - majloma multipla - aġenti antineoplastiċi - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - aġenti antitrombotiċi - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan 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.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

tmc pharma services ltd. - gadofosveset trisodium - anġjografija b'reżonanza manjetika - midja ta 'kuntrast - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. ablavar huwa indikat għall-kuntrast imtejjeb għal anġjografija b'reżonanza manjetika (ce-mra) għall-viżwalizzazzjoni tal-addominali jew fil-vini tar-riġlejn fl-adulti biss, ma suspettati jew magħrufa mard vaskulari.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - aġenti antitrombotiċi - xarelto, mogħti flimkien ma 'acetylsalicylic acid (asa) waħdu jew ma' asa flimkien ma ' clopidogrel jew ticlopidine, huwa indikat għall-prevenzjoni ta'avvenimenti aterotrombotiċi f'pazjenti adulti wara l-sindromu koronarju akut (acs) mal-bijomarkaturi kardijaċi għoljin. 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. prevenzjoni ta ' l-thromboembolism venous (vte) fil-pazjenti adulti li għaddejjin minn elettiva għadma jew irkoppa sostituzzjoni kirurġija. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris healthcare limited - tolcapone - marda ta 'parkinson - kontra l-marda ta ' parkinson id-drogi, aġenti dopaminerġiċi oħra - tasmar hija indikata fil kombinazzjoni ma ' ticlopidine hydrochloride / benserazide jew ticlopidine hydrochloride / carbidopa għall-użu fil-pazjenti ma ticlopidine hydrochloride-responsivi idiopathic parkinson's marda u oxxillazzjonijiet vetturi bil-mutur, li naqas milli jirrispondi għal jew huma intolerant ta ' xulxin inibituri ta ' catechol-o-methyltransferase (comt). minħabba r-riskju ta potenzjalment fatali, ħsara fil-fwied akut, tasmar ma għandhomx jiġu kkunsidrati bħala l-ewwel linja ta 'trattament miżjud ma' levodopa / benserazide jew levodopa / carbidopa. peress li tasmar għandu jiġi użat biss flimkien ma 'levodopa / benserazide u b'levodopa / carbidopa, l-tagħrif preskritt individwalment għal dawn l-sustanzi ta' levodopa hija applikabbli għall-użu tagħhom flimkien ma ' tasmar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda manufacturing austria ag - impeditur c1 (uman) - angioedemas, ereditarji - c1-inibitur, derivat mill-plażma, mediċini wżati fil anġjoedema ereditarja - trattament u prevenzjoni ta 'attakki ta' anġjoedema f'adulti, adolexxenti u tfal (sentejn u aktar) b'anġjoedema ereditarja (hae). rutina għall-prevenzjoni ta'l-attakki tal-anġjoedema fl-adulti, l-adoloxxenti u t-tfal (6 snin u l-fuq) bil-qawwi u rikorrenti l-attakki ta 'anġjodemija ereditarja (hae), li huma intolleranti għal, jew mhux biżżejjed protetti mill-ħalq l-prevenzjoni tal-trattamenti, jew pazjenti li mhumiex adegwatament ġestiti bl-ripetuti ta' kura akuta.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - pregabalin - anxiety disorders; epilepsy - anti-epilettiċi, - epilepsypregabalin qbil huwa indikat bħala terapija aġġuntiva f'persuni adulti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja. ta'ansjetà ġeneralizzata disorderpregabalin qbil huwa indikat għall-kura ta 'disturb ta' ansjetà Ġeneralizzata (gad-generalised anxiety disorder) f'persuni adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mallinckrodt deutschland gmbh - gadoversetamide - immaġni tar-reżonanza manjetika - midja ta 'kuntrast - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. optimark hu indikat għall-użu mal-immaġni tar-reżonanza manjetika (mri) tas-sistema nervuża ċentrali (cns) u l-fwied. jipprovdi titjib tal-kuntrast u jiffaċilita l-viżwalizzazzjoni u jgħin fil-karatterizzazzjoni tal-leżjonijiet fokali u strutturi anormali fis-cns u fil-fwied f'pazjenti b'magħrufa jew issuspettata patoloġija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

holostem s.r.l - ex vivo espanda ċelloli umani awtoloġiċi kornea epithelial li jkun fih iċ-ċelloli staminali - stem cell transplantation; corneal diseases - oftalmoloġiċi - trattament tal-pazjenti adulti ma moderat għal defiċjenza ta ' ċelluli staminali limbal severa (definiti bil-preżenza ta ' l-neovascularisation superfiċjali tal-kornea fi mill-anqas żewġ kwadranti tal-kornea, bl-involviment ċentrali tal-kornea, u severament imfixkla akutezza), unilaterali jew bilaterali, minħabba l-ħruq okulari fiżiċi jew kimiċi. minimu ta '1-2 mm2 ta' limbus imbattal huwa meħtieġ għall-bijopsija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

corza medical gmbh - fibrinoġen uman, trombina umana - hemostasi, kirurġiċi - sustanzi kontra l-emorraġija - tachosil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. tachosil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.