Европейский союз - мальтийский - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofilja b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Европейский союз - мальтийский - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - pegunigalsidase alfa - marda ta 'fabry - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Европейский союз - мальтийский - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - infezzjonijiet ta 'virus sintetiku respiratorju - vaċċini - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Европейский союз - мальтийский - EMA (European Medicines Agency)

merck sharp & dohme b.v. - gefapixant - cough - sogħla u preparazzjonijiet kesħin - lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.

Европейский союз - мальтийский - 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.

Европейский союз - мальтийский - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - atogepant - disturbi fl-emigranja - aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Европейский союз - мальтийский - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - newtropenja - immunostimulanti, - accofil 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 minn trapjant tal-mudullun li huma kkunsidrati li jkunu f'riskju akbar fit-tul ta ' newtropenja severa. is-sigurtà u l-effikaċja ta 'accofil huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. accofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs). 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 'infezzjonijiet severi jew rikorrenti, l-amministrazzjoni fit-tul ta' accofil hija indikata biex iżżid l-għadd ta 'newtrofili u biex tnaqqas l-inċidenza u t-tul ta' avvenimenti relatati mal-infezzjonijiet. accofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 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.

Европейский союз - мальтийский - EMA (European Medicines Agency)

ferrer internacional s.a. - loxapine - schizophrenia; bipolar disorder - sistema nervuża - adasuve huwa indikat għall-kontroll rapidu ta 'aġitazzjoni ħafifa għal moderata f'pazjenti adulti bi skiżofrenja jew disturb bipolari. il-pazjenti għandhom jirċievu trattament regolari immedjatament wara l-kontroll ta 'sintomi ta' aġitazzjoni akuta.

Европейский союз - мальтийский - EMA (European Medicines Agency)

bayer ag - riociguat - pressjoni għolja, pulmonari - antihypertensives għall-ipertensjoni arterjali pulmonari - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. l-effikaċja ġiet murija fil-pah popolazzjoni inklużi l-etjoloġiji ta idjopatika jew li tintiret-pah jew pah assoċċjata ma'mard tal-connective tissue. paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

Европейский союз - мальтийский - EMA (European Medicines Agency)

astellas pharma europe bv - tacrolimus - rifjut ta 'graft - immunosoppressanti - profilassi tar-rifjut tat-trapjanti f'riċevituri ta 'l-alloġib tal-kliewi jew tal-fwied adulti. kura ta 'rifjut tal-allograft reżistenti għat-trattament ma' prodotti mediċinali immunosoppressivi oħra f'pazjenti adulti.