Европейски съюз - малтийски - EMA (European Medicines Agency)

the medicines company uk ltd - bivalirudin - sindromu koronarju akut - aġenti antitrombotiċi - angiox huwa indikat bħala antikoagulant f'pazjenti adulti li għaddejjin minn intervent koronarju perkutanju (pci), inklużi pazjenti b'infezzjoni mijokardijaka ta 'elevazzjoni tas-segment st (stemi) li għaddejjin minn pci primarju. angiox huwa wkoll indikat għall-kura ta ' pazjenti adulti b'anġina instabbli / mhux-st segment tal-elevazzjoni tal-infart mijokardijaku (ua / nstemi) ippjanati għal intervent urġenti jew bikri. angiox għandu jingħata ma ' aspirina u clopidogrel.

Европейски съюз - малтийски - EMA (European Medicines Agency)

astrazeneca ab - palivizumab - infezzjonijiet ta 'virus sintetiku respiratorju - sera immuni u immunoglobulini, - synagis huwa indikat għall-prevenzjoni ta serji aktar baxx respiratorju-passaġġ-marda li jeħtieġu kura fl-isptar kkawżat mill-virus sinktjali respiratorju (rsv), fi tfal b'riskju għoli għall-marda rsv:it-tfal li twieldu wara 35 ġimgħa ta 'ġestazzjoni jew inqas u inqas minn età ta' sitt xhur fil-bidu tal-istaġun ta 'rsv;tfal ta' inqas minn sentejn u li jeħtieġu trattament għad-displasja bronkopulmonari fl-aħħar sitt xhur;tfal ta ' inqas minn sentejn u bil-ħruġ emodinamikament sinifikanti ta mard tal-qalb konġenitali.

Европейски съюз - малтийски - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - il-prodotti terapewtiċi l-oħra kollha - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

Европейски съюз - малтийски - EMA (European Medicines Agency)

viiv healthcare b.v. - cabotegravir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4. 2, 4. 4 u 5.

Европейски съюз - малтийски - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - ibandronic acid - l-osteoporożi, il-menopawża - drogi għat-trattament ta 'mard tal-għadam - it-trattament ta'l-osteoporożi f'nisa wara l-menopawża f'riskju miżjud ta'ksur (ara sezzjoni 5. tnaqqis fir-riskju ta ' ksur vertebrali ġie muri, l-effikaċja fuq il-ksur fl-għonq tal-femora ma ġietx stabbilita.

Европейски съюз - малтийски - 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.

Европейски съюз - малтийски - EMA (European Medicines Agency)

pfizer limited - pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14 - pneumococcal infections; immunization - vaċċini - attiva tilqim kontra mard ikkawżat minn streptococcus pneumoniae serotipi 4, 6b, 9v, 14, 18 c, 19f u 23f (inklużi sepsis, meninġite, pnewmonja, bacteraemia u otiti medja akuta) fit-trabi u tfal minn xahrejn sa ħames snin ta ' età. l-użu ta 'prevenar għandu jkun stabbilit fuq il-bażi ta' rakkomandazzjonijiet uffiċjali filwaqt li jitqiesu l-impatt ta 'mard invażiv fi gruppi differenti ta' età, kif ukoll il-varjabilità tal-epidemjoloġija tas-serotip f'żoni ġeografiċi differenti.

Европейски съюз - малтийски - EMA (European Medicines Agency)

biogen idec ltd - daclizumab - sklerosi multipla - immunosoppressanti - zinbryta huwa indikat f'pazjenti adulti għat-trattament ta 'forom ta' sklerożi multipla li tirkadi (rms).

Европейски съюз - малтийски - EMA (European Medicines Agency)

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. axumin huwa indikat għall-positron emission tomography (pet) tal-immaġini biex jidentifikaw ir-rikorrenza tal-kanċer tal-prostata fl-irġiel adulti b'suspett rikorrenza bbażata fuq l-għoli fid-demm antiġen speċifiku għall-prostata (psa) livelli wara l-ewwel trattament kurattiv.

Европейски съюз - малтийски - EMA (European Medicines Agency)

teva gmbh - fremanezumab - disturbi fl-emigranja - calcitonin gene-related peptide (cgrp) antagonists - ajovy huwa indikat għall-profilassi ta ' l-emigranja fl-adulti li jkollhom mill-anqas 4-emigranja jiem kull xahar.