Cresemba Unjoni Ewropea - Malti - EMA (European Medicines Agency)

cresemba

basilea pharmaceutica deutschland gmbh - isavuconazole - asperġillożi - cresemba huwa indikat fl-adulti għall-kura ta': invażivi aspergillosismucormycosis fil-pazjenti li għalihom amphotericin b huwa inappropriateconsideration għandha tingħata lill-gwida uffiċjali dwar l-użu xieraq ta ' mediċini antifungali.

Infanrix Hexa Unjoni Ewropea - Malti - EMA (European Medicines Agency)

infanrix hexa

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaċċini - infanrix hexa huwa indikat għall-vaċċinazzjoni primarja u booster tat-trabi kontra diphtheria, tetanus, pertussis, epatite b, poliomyelitis u mard ikkawżat minn influwenza Ħemofillika tip-b.

Mhyosphere PCV ID Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mhyosphere pcv id

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - majjali - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Granupas (previously Para-aminosalicylic acid Lucane) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

granupas (previously para-aminosalicylic acid lucane)

eurocept international b. v. - para-aminosalicylic acid - tuberkulożi - antimikobatterjali - granupas huwa indikat għall-użu bħala parti mill-dożaġġ tal-kombinazzjoni xierqa għat-tuberkolożi reżistenti ħafna tad-droga fl-adulti u l-pazjenti pedjatriċi minn 28 jum ta ' l-età u l-eqdem meta xi skoperta trattament effettiv ma jistax inkella jkun magħmul għal raġunijiet ta ' l- reżistenza jew tolerability (ara taqsima 4. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Bekemv Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bekemv

amgen technology (ireland) uc - eculizumab - emoglobinurja, paroxysmal - immunosoppressanti - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). l-evidenza ta 'benefiċċju kliniku hija murija f'pazjenti b'emodijalisi ma' sintomi kliniċi(i) indikattiv ta'l-attività għolja tal-marda, irrispettivament mill-trasfużjoni-istorja (ara sezzjoni 5.

Coliprotec F4 Unjoni Ewropea - Malti - EMA (European Medicines Agency)

coliprotec f4

prevtec microbia gmbh - escherichia coli ħajjin mhux patoġeniċi o8: k87 - immunologicals for suidae, live bacterial vaccines, pig - majjali - għall-immunizzazzjoni attiva tal-majjali kontra l-enterotoxigenic f4-pożittivi escherichia coli sabiex:naqqas l-inċidenza ta moderat għal sever ta ' wara l-ftim escherichia coli dijarea (proĊessi) fil-ħnieżer;jitnaqqas il-kolonizzazzjoni tal-ileu u fekali-tixrid ta'enterotoxigenic f4-pożittivi escherichia coli minn ħnieżer infettati.

Neocolipor Unjoni Ewropea - Malti - EMA (European Medicines Agency)

neocolipor

boehringer ingelheim vetmedica gmbh - e. coli adhesin f4 (f4ab, f4ac, f4ad), e. coli adhesin f5, e. coli adhesin f6, e. coli adhesin f41 - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - sows; sows (nullipar) - tnaqqis ta 'enterotossikożi tat-twelid tal-ħnienes, ikkawżat minn e. coli strains, li jesprimu l-adesini f4ab, f4ac, f4ad, f5, f6 u f41, matul l-ewwel jiem tal-ħajja.

Prevenar 13 Unjoni Ewropea - Malti - EMA (European Medicines Agency)

prevenar 13

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - vaċċini - immunizzazzjoni attiva għall-prevenzjoni ta 'mard invażiv, pnewmonja u otite medja akuta kkawżata minn streptococcus pneumoniae fi trabi, tfal u adolexxenti minn 6 ġimgħat sa 17-il sena. l-immunizzazzjoni attiva, għall-prevenzjoni ta'mard invażiv ikkawżat minn streptococcus pneumoniae fl-adulti ≥18-il sena u anzjani. ara t-taqsimiet 4. 4 u 5. 1 għal informazzjoni dwar il-protezzjoni kontra serotipi pnewmokokkiċi speċifiċi. l-użu ta 'prevenar 13 għandu jiġi determinat fuq il-bażi ta' rakkomandazzjonijiet uffiċjali filwaqt li jitqiesu r-riskju ta 'mard invażiv fi gruppi differenti ta' età, sottostanti ' ko-morbożità kif ukoll il-varjabilità tal-epidemjoloġija tas-serotip f'żoni ġeografiċi differenti.

Prevenar Unjoni Ewropea - Malti - EMA (European Medicines Agency)

prevenar

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.

Nyxthracis (previously Obiltoxaximab SFL) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

nyxthracis (previously obiltoxaximab sfl)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - sera immuni u immunoglobulini, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.