Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosoppressanti - leflunomide huwa indikat għall-kura ta ' pazjenti adulti bil:artrite rewmatika attiva bħala 'mard tal-anti-rewmatiċi li jimmodifikaw il-mediċina' (dmard);artrite psorjatika attiva. riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic dmards (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. barra minn hekk, il-qlib minn leflunomide għal dmard ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zentiva k.s. - riluzole - sklerożi laterali amyotrophic - drogi oħra tas-sistema nervuża - riluzole zentiva huwa indikat biex jestendi l-ħajja jew il-ħin għall-ventilazzjoni mekkanika għal pazjenti bi sklerożi laterali amjotrofika (als). clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. is-sopravivenza kienet definita bħala il-pazjenti li kienu ħajjin, ma intubated għal ventilazzjoni mekkanika u l-tracheotomy-free. ma hemm l-ebda evidenza li riluzole zentiva jeżerċita effett terapewtiku fuq funzjoni motorili, funzjoni tal-pulmun, faxxikulazzjonijiet, saħħa muskolari u sintomi motorili. riluzole zentiva ma ntweriex li hu effettiv fl-aħħar stadji ta ' als. is-sigurtà u l-effikaċja ta ' riluzole zentiva kien studjat biss fl-als. għalhekk, riluzole zentiva m'għandux jintuża f'pazjenti li għandhom xi forma oħra ta'vetturi bil-mutur-mard tan-newroni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosoppressanti - leflunomide huwa indikat għall-kura ta ' pazjenti adulti bil:artrite rewmatika attiva bħala 'mard tal-anti-rewmatiċi li jimmodifikaw il-mediċina' (dmard);artrite psorjatika attiva. riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic dmards (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. barra minn hekk, il-qlib minn leflunomide għal dmard ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - sklerosi multipla - immunosuppressanti selettivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - riluzole - sklerożi laterali amyotrophic - drogi oħra tas-sistema nervuża - rilutek huwa indikat li jestendu l-ħajja jew il-ħin għall-mekkanika tal-ventilazzjoni għall-pazjenti b ' amyotrophic laterali sclerosis (als). provi kliniċi wrew li rilutek testendi s-sopravivenza għall-pazjenti bl-als. is-sopravivenza kienet definita bħala il-pazjenti li kienu ħajjin, ma intubated għal ventilazzjoni mekkanika u l-tracheotomy-free. ma hemm l-ebda evidenza li rilutek jeżerċita effett terapewtiku fuq funzjoni motorili, funzjoni tal-pulmun, faxxikulazzjonijiet, saħħa muskolari u sintomi motorili. rilutek ma ntweriex li hu effettiv fl-aħħar stadji ta ' als. is-sigurtà u l-effikaċja ta ' rilutek kienu studjati biss f'dawk li jbatu minn als. għalhekk, rilutek m'għandux jintuża f'pazjenti li għandhom xi forma oħra ta'vetturi bil-mutur-mard tan-newroni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - formoterol fumarate dihydrate, glycopyrronium, beclometasone dipropionate - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - trattament ta ' manutenzjoni fil-pazjenti adulti ma moderat severi kronika eliminat pulmonari marda (copd) li m'humiex ittrattati adegwatament mill-għaqda tal-corticosteroid bin-nifs u a twila u jaġixxu beta2-agonist (għall-effetti fuq is-sintomi kontroll u prevenzjoni ta ' exacerbations ara taqsima 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - trattament ta ' manutenzjoni fil-pazjenti adulti ma moderat severi kronika eliminat pulmonari marda (copd) li m'humiex ittrattati adegwatament mill-għaqda tal-corticosteroid bin-nifs u a twila u jaġixxu beta2-agonist (għall-effetti fuq is-sintomi kontroll u prevenzjoni ta ' exacerbations ara taqsima 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. copdmaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5. asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - riltrava aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.