Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ceva santé animale - organiżmi ġenetikament modifikati rikombinanti shiga-tossina-2c-antiġen - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - majjali - immunizzazzjoni attiva ta 'qżieqeż mill-età ta' erbat ijiem, biex titnaqqas il-mortalità u sinjali kliniċi ta ' edima l-mard ikkawżat mill-shiga-tossina 2c prodotti minn escherichia coli (stec). il-bidu tal-immunità: 21 jum wara t-tilqima. tul ta 'żmien ta' l-immunità: 105 jum wara t-tilqima.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zoetis belgium sa - virus tal-west nile inattivat, razza vm-2 - immunoloġiċi għall-equidae - Żwiemel - għall-immunizzazzjoni attiva ta 'żwiemel ta' sitt xhur jew akbar kontra l-marda tal-virus tal-west-nile billi tnaqqas in-numru ta 'żwiemel viraemiċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - kvp 2242 virus / vcp1529 virus / għal vcp1533 għal virus / vcp3011 virus - immunoloġiċi, vaċċini virali Ħajjin virus tal-influwenza ekwina - Żwiemel - immunizzazzjoni attiva ta 'żwiemel ta' erba 'xhur jew aktar kontra l-influwenza taż-żwiemel biex jitnaqqsu s-sinjali kliniċi u l-eskrezzjoni tal-virus wara l-infezzjoni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - clostridium tetani toxoid / kvp 2242 virus / vcp1529 virus / għal vcp1533 għal virus / vcp3011 virus - immunologicals for equidae, live viral and inactivated bacterial vaccines, equine influenza virus + clostridium - Żwiemel - immunizzazzjoni attiva ta 'żwiemel ta' erba 'xhur jew akbar kontra l-influwenza taż-żwiemel biex jitnaqqsu s-sinjali kliniċi u l-eskrezzjoni tal-virus wara infezzjoni, u kontra t-tetnu biex tiġi evitata l-mortalità.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

dechra regulatory b.v. - pivalate ta 'desoxycortone - kortikosterojdi għal użu sistemiku - klieb - għall-użu bħala terapija ta ' sostituzzjoni għall-mineralocorticoid defiċjenza fil-klieb b'primarja iperadrenokortiċiżmu (addison tal-marda).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - eptifibatide - angina, unstable; myocardial infarction - aġenti antitrombotiċi - integrilin huwa maħsub għall-użu ma 'acetylsalicylic acid u heparin mhux frazzjonat. integrilin huwa indikat għall-prevenzjoni ta 'infart mijokardijaku bikri f'pazjenti li jippreżentaw b'anġina instabbli jew mhux-mewġa-q infart mijokardijaku bl-aħħar episodju ta' uġigħ fis-sider li jseħħu fi żmien 24 siegħa u mal-bidliet fl-ecg u / jew enzimi kardijaċi elevati. il-pazjenti l-aktar probabbli li jibbenefikaw mill-integrilin-trattament huma dawk f'riskju għoli li jiżviluppaw infart mijokardijaku fi żmien l-ewwel 3-4 ijiem wara l-bidu ta 'anġina' sintomi, inkluż pereżempju dawk li huma probabbli li jgħaddu minn kmieni koronarju perkutanju transluminali l-anġoplastika (ptca).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - guanfacine hydrochloride - tnaqqis tad-defiċit ta 'l-attenzjoni b'hérapectivity - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv għandhom ikunu użati bħala parti minn komprensiva adhd-programm tat-trattament, tipikament inkluż psikoloġiċi, l-edukazzjoni u l-miżuri soċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mukosite - il-prodotti terapewtiċi l-oħra kollha - kepivance huwa indikat li tnaqqas l-inċidenza, it-tul u s-severità tal-mucositis orali fil-pazjenti adulti ma malignancies ħematoloġiċi li jirċievu radiochemotherapy ta ' myeloablative assoċjati ma ' l-inċidenza għolja ta ' mucositis ħorox u li jeħtieġu haematopoietic-zokk-ċelloli awtoloġiċi appoġġ.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - lopinavir, ritonavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - lopinavir / ritonavir huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' adulti infettati bil-virus tal-immunodefiċjenza umana (hiv-1), adolexxenti u tfal 'il fuq minn sentejn. l-għażla ta 'lopinavir/ritonavir għall-kura ta' impedituri protease tal-hiv-1 f'pazjenti infettati għandha tkun ibbażata fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjenti.