FrancophonIA/ELRC3.0 huggingface dataset:
English: The second Phase 3 trial (FACETS) was a 6-month randomised double-blind placebo-controlled trial (through month 6) with an 18-month open-label period to evaluate the efficacy and safety of Galafold in 50 male and female patients with Fabry disease who were naïve to ERT, or had previously been on ERT and had stopped for at least 6 months and who have amenable mutations (ERT-naïve trial).
French: Le deuxième essai de phase 3 (FACETS) était une étude randomisée, en double aveugle, contrôlée versus placebo (pendant 6 mois), suivie d'une période d'extension en ouvert de 18 mois évaluant l'efficacité et la sécurité de Galafold chez 50 patients de sexe masculin ou féminin atteints de la maladie de Fabry.
English: c.G870A or c.G870C or c.G870T M290I
French: c.G870A ou c.G870C ou c.G870T M290I
English: c.228G>C or c.228G>A or c.228G>T
French: c.228G>C ou c.228G>A ou c.228G>T
English: c.412G>A or c.412G>C
French: c.412G>A ou c.412G>C
English: c.G228C or c.G228A or c.G228T M76I
French: c.G228C ou c.G228A ou c.G228T M76I
English: c.T241C or c.T241A
French: c.T241C ou c.T241A
English: c.280T>A or c.281G>C
French: c.280T>A ou c.281G>C
English: c.G982A or c.G982C
French: c.G982A ou c.G982C
English: c.153G>A or c.153G>T or c.153G>C
French: c.153G>A ou c.153G>T ou c.153G>C
English: • Feeling sick (nausea)
French: • Envie de vomir (nausées)
English: c.159C>G or c.159C>A
French: c.159C>G ou c.159C>A
English: c.T881G or c.T881A
French: c.T881G ou c.T881A
English: PUSH card back into holder
French: REPLACER la plaquette dans la boîte.
English: c.817T>C or c.819T>A or c.819T>G
French: c.817T>C ou c.819T>A ou c.819T>G
English: c.G540C or c.G540T
French: c.G540C ou c.G540T
English: c.G285T or c.G285C
French: c.G285T ou c.G285C
English: c.C233G or c.C233A
French: c.C233G ou c.C233A
English: c.337T>C or c.339T>A or c.339T>G
French: c.337T>C ou c.339T>A ou c.339T>G
English: c.C279G or c.C279A
French: c.C279G ou c.C279A
English: c.G612T or c.G612C
French: c.G612T ou c.G612C
English: c.C525G or c.C525A
French: c.C525G ou c.C525A
English: 92.9 g/m for the ERT arm and the mean change from baseline in LVMi at Month 18 was -6.6 (95% CI: -11.0, -2.1; n=31) for Galafold and -2.0 (95% CI: -11.0, 7.0; n=13) for ERT.
French: La variation moyenne de l'index de masse ventriculaire gauche (IMVG) au mois 18 par rapport à sa valeur initiale était de -6,6 g/m2 (IC à 95 %: -11,0, -2,1; n = 31) pour le Galafold et de -2,0 g/m2 (IC à 95 %: -11,0, 7,0; n = 13) pour le TES.
English: c.T166A or c.G167C
French: c.T166A ou c.G167C
English: c.G261C or c.G261T
French: c.G261C ou c.G261T
English: c.G242A or c.G243A
French: c.G242A ou c.G243A
English: c.G131A or c.G132A
French: c.G131A ou c.G132A
English: c.285G>T or c.285G>C
French: c.285G>T ou c.285G>C
English: c.187T>A or c.188G>C
French: c.187T>A ou c.188G>C
English: c.G471C or c.G471T
French: c.G471C ou c.G471T
English: c.284G>A or c.285G>A
French: c.284G>A ou c.285G>A
English: c.261G>C or c.261G>T
French: c.261G>C ou c.261G>T
English: c.612G>T or c.612G>C
French: c.612G>T ou c.612G>C
English: • Persistent itch (pruritus)
French: • Démangeaisons persistantes (prurit)
English: c.241T>C or c.241T>A
French: c.241T>C ou c.241T>A
English: c.G734A or c.G735A
French: c.G734A ou c.G735A
English: c.519C>A or c.519C>G
French: c.519C>A ou c.519C>G
English: c.G1074T or c.G1074C
French: c.G1074T ou c.G1074C
English: c.T552A or c.T552G
French: c.T552A ou c.T552G
English: On your first day of taking this medicine from a new blister sleeve, record the date on the blister sleeve.
French: Lorsque vous entamez une nouvelle boîte de plaquette, notez la date de prise de la première gélule sur celle-ci.
English: c.982G>A or c.982G>C
French: c.982G>A ou c.982G>C
English: c.124A>C or c.124A>T
French: c.124A>C ou c.124A>T
English: c.C305G or c.C305A
French: c.C305G ou c.C305A
English: c.G888A or c.G888T or c.G888C M296I
French: c.G888A ou c.G888T ou c.G888C M296I
English: c.552T>A or c.552T>G
French: c.552T>A ou c.552T>G
English: c.242G>A or c.243G>A
French: c.242G>A ou c.243G>A
English: c.C453G or c.C453A
French: c.C453G ou c.C453A
English: c.C747G or c.C747A
French: c.C747G ou c.C747A
English: c.207C>A or c.207C>G
French: c.207C>A ou c.207C>G
English: c.T258G or c.T258A
French: c.T258G ou c.T258A
English: c.471G>C or c.471G>T
French: c.471G>C ou c.471G>T
English: c.T514A or c.G515C
French: c.T514A ou c.G515C
English: c.G144T or c.G144C
French: c.G144T ou c.G144C
English: c.G1081A or c.G1081C
French: c.G1081A ou c.G1081C
English: c.G132T or c.G132C
French: c.G132T ou c.G132C
English: In the ERT-naïve trial, Galafold resulted in a statistically significant decrease in LVMi (p< 0.05); the mean change from baseline in LVMi at Month 18 to 24 was -7.7 (95% CI: -15.4, -0.01; n=27).
French: Dans l'essai mené chez des patients n'ayant jamais reçu de TES, Galafold a entraîné une réduction statistiquement significative de l'IMVG (p< 0,05); la variation moyenne de l'IMVG entre l'inclusion et la période allant du 18ème au 24ème mois était de -7,7 (IC à 95 %: -15,4, -0,01; n = 27).
English: c.G609C or c.G609T
French: c.G609C ou c.G609T
English: c.A840T or c.A840C
French: c.A840T ou c.A840C
English: c.G243T or c.G243C
French: c.G243T ou c.G243C
English: c.132G>T or c.132G>C
French: c.132G>T ou c.132G>C
English: c.1081G>A or c.1081G>C
French: c.1081G>A ou c.1081G>C
English: c.G288A or c.G288T or c.G288C M96I
French: c.G288A ou c.G288T ou c.G288C M96I
English: c.1074G>T or c.1074G>C
French: c.1074G>T ou c.1074G>C
English: c.C897G or c.C897A
French: c.C897G ou c.C897A
English: UNKNOWN (del Exon3?)
French: INCONNU (del Exon3?)
English: c.G567C or c.G567T
French: c.G567C ou c.G567T
English: c.T154A or c.G155C
French: c.T154A ou c.G155C
English: c.T280A or c.G281C
French: c.T280A ou c.G281C
English: c.279C>G or c.279C>A
French: c.279C>G ou c.279C>A
English: After follow up in the OLE, the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline at Month 36 was -30.0 (95%) CI: -57.9, -2.2; n=4) and at Month 48
French: Après le suivi dans l'étude d'extension en ouvert, la variation moyenne de l'IMVG chez les patients atteints d'une hypertrophie du ventricule gauche à l'inclusion entre le début de l'essai et le 36ème mois était de -30,0 (IC à 95 % : -57,9, -2,2 ; n = 4), et le 48ème mois était de -33,1
English: c.T960G or c.T960A
French: c.T960G ou c.T960A
English: c.816C>A or c.816C>G
French: c.816C>A ou c.816C>G
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
French: Si vous planifiez une grossesse, demandez conseil à votre médecin ou à votre pharmacien.
English: c.540G>C or c.540G>T
French: c.540G>C ou c.540G>T
English: c.525C>G or c.525C>A
French: c.525C>G ou c.525C>A
English: c.103G>C or c.103G>A
French: c.103G>C ou c.103G>A
English: • Tingling in extremities
French: • Fourmillements dans les extrémités (paresthésies)
English: c.233C>G or c.233C>A
French: c.233C>G ou c.233C>A
English: c.243G>T or c.243G>C
French: c.243G>T ou c.243G>C
English: c.144G>T or c.144G>C
French: c.144G>T ou c.144G>C
English: UNKNOWN (del Exon1_2?)
French: INCONNU (del Exon1_2?)
English: - If you get any side effects, talk to your doctor, pharmacist, or nurse.
French: - Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin, votre pharmacien ou à votre infirmier/ère.
English: c.T610C or c.T610A
French: c.T610C ou c.T610A
English: c.258T>G or c.258T>A
French: c.258T>G ou c.258T>A
English: c.A588T or c.A588C
French: c.A588T ou c.A588C
English: c.T859C or c.T859A
French: c.T859C ou c.T859A
English: c.881T>G or c.881T>A
French: c.881T>G ou c.881T>A
English: UNKNOWN (del Exon5_7?)
French: INCONNU (del Exon5_7?)
English: c.G831T or c.G831C
French: c.G831T ou c.G831C
English: c.707G>A or c.708G>A
French: c.707G>A ou c.708G>A
English: c.G141C or c.G141T
French: c.G141C ou c.G141T
English: c.108G>C or c.108G>T
French: c.108G>C ou c.108G>T
English: c.G830A or c.G831A
French: c.G830A ou c.G831A
English: c.T408A or c.T408G
French: c.T408A ou c.T408G
English: c.609G>C or c.609G>T
French: c.609G>C ou c.609G>T
English: c.610T>C or c.610T>A
French: c.610T>C ou c.610T>A
English: c.T369G or c.T369A
French: c.T369G ou c.T369A
English: c.166T>A or c.167G>C
French: c.166T>A ou c.167G>C
English: Table 2: Galafold (migalastat) amenability table
French: Tableau 2: Mutations sensibles à Galafold (migalastat)
English: c.567G>C or c.567G>T
French: c.567G>C ou c.567G>T
English: c.830G>A or c.831G>A
French: c.830G>A ou c.831G>A
English: c.453C>G or c.453C>A
French: c.453C>G ou c.453C>A
English: c.831G>T or c.831G>C
French: c.831G>T ou c.831G>C
English: c.870G>A or c.870G>C or c.870G>T
French: c.870G>A ou c.870G>C ou c.870G>T
English: c.734G>A or c.735G>A
French: c.734G>A ou c.735G>A
English: c.141G>C or c.141G>T
French: c.141G>C ou c.141G>T
English: c.960T>G or c.960T>A
French: c.960T>G ou c.960T>A
English: c.G485A or c.G486A
French: c.G485A ou c.G486A
English: c.305C>G or c.305C>A
French: c.305C>G ou c.305C>A
English: c.T465A or c.T465G
French: c.T465A ou c.T465G
English: c.G108C or c.G108T
French: c.G108C ou c.G108T
English: c.G71A or c.G72A
French: c.G71A ou c.G72A
English: c.G860A or c.G861A
French: c.G860A ou c.G861A
English: • Nose bleed (epistaxis)
French: • Saignements de nez (épistaxis)
English: c.888G>A or c.888G>T or c.888G>C
French: c.888G>A ou c.888G>T ou c.888G>C
English: c.71G>A or c.72G>A
French: c.71G>A ou c.72G>A
English: c.C456A or c.C456G
French: c.C456A ou c.C456G
English: c.439G>A or c.439G>C
French: c.439G>A ou c.439G>C
English: c.C966A or c.C966G
French: c.C966A ou c.C966G
English: c.G861C or c.G861T
French: c.G861C ou c.G861T
English: c.859T>C or c.859T>A
French: c.859T>C ou c.859T>A
English: c.G394A or c.G394C
French: c.G394A ou c.G394C
English: c.G439A or c.G439C
French: c.G439A ou c.G439C
English: c.860G>A or c.861G>A
French: c.860G>A ou c.861G>A
English: • Reduced sense of touch or sensation
French: • Diminution de la sensibilité du toucher (hypoesthésies)
English: c.T676C or c.T676A
French: c.T676C ou c.T676A
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat.
French: COMPOSITION QUALITATIVE ET QUANTITATIVE Chaque gélule contient 123 mg de migalastat, sous forme de chlorhydrate de migalastat.
English: c.G486C or c.G486T
French: c.G486C ou c.G486T
English: c.514T>A or c.515G>C
French: c.514T>A ou c.515G>C
English: c.394G>A or c.394G>C
French: c.394G>A ou c.394G>C
English: c.G837C or c.G837T
French: c.G837C ou c.G837T
English: (95% CI: -1.89, 0.40; n=41).
French: à 95 %: -38,2, 1,0; n = 8).
English: c.T70C or c.T70A
French: c.T70C ou c.T70A
English: c.897C>G or c.897C>A
French: c.897C>G ou c.897C>A
English: After an average of 3.4 years of treatment, the mean annualised rate of change in eGFRCKD-EPI was -0.74 mL/min/1.73 m
French: Après une durée moyenne de traitement de 3,4 années , la variation annuelle moyenne du DFGeCKD-EPI était de -0,74 ml/min/1,73 m2 (IC à 95 %: -1,89, 0,40 ; n = 41).
English: c.T667A or c.G668C
French: c.T667A ou c.G668C
English: c.G936T or c.G936C
French: c.G936T ou c.G936C
English: c.154T>A or c.155G>C
French: c.154T>A ou c.155G>C
English: c.966C>A or c.966C>G
French: c.966C>A ou c.966C>G
English: c.840A>T or c.840A>C
French: c.840A>T ou c.840A>C
English: c.708G>C or c.708G>T
French: c.708G>C ou c.708G>T
English: c.T648A or c.T648G
French: c.T648A ou c.T648G
English: c.485G>A or c.486G>A
French: c.485G>A ou c.486G>A
English: c.588A>T or c.588A>C
French: c.588A>T ou c.588A>C
English: c.288G>A or c.288G>T or c.288G>C
French: c.288G>A ou c.288G>T ou c.288G>C
English: c.T834G or c.T834A
French: c.T834G ou c.T834A
English: c.A868C or c.A868T
French: c.A868C ou c.A868T
English: c.102T>G or c.102T>A
French: c.102T>G ou c.102T>A
English: c.465T>A or c.465T>G
French: c.465T>A ou c.465T>G
English: UNKNOWN (del Exon3_7?)
French: INCONNU (del Exon3_7?)
English: c.861G>C or c.861G>T
French: c.861G>C ou c.861G>T
English: c.T102G or c.T102A
French: c.T102G ou c.T102A
English: c.456C>A or c.456C>G
French: c.456C>A ou c.456C>G
English: c.G707A or c.G708A
French: c.G707A ou c.G708A
English: c.834T>G or c.834T>A
French: c.834T>G ou c.834T>A
English: c.408T>A or c.408T>G
French: c.408T>A ou c.408T>G
English: c.T687A or c.T687G
French: c.T687A ou c.T687G
English: c.T484C or c.T484A
French: c.T484C ou c.T484A
English: c.676T>C or c.676T>A
French: c.676T>C ou c.676T>A
English: c.70T>C or c.70T>A
French: c.70T>C ou c.70T>A
English: c.G963C or c.G963T
French: c.G963C ou c.G963T
English: The mean change from baseline in LVMi at Month 18 to 24 in patients with left ventricular hypertrophy at baseline (females with baseline LVMi > 95 g/m or males with baseline LVMi > 115 g/m 2) was -18.6 (95% CI: -38.2, 1.0; n=8).
French: La variation moyenne de l'IMVG entre l'inclusion et la période allant du 18ème au 24ème mois chez les patients présentant une hypertrophie du ventricule gauche à l'inclusion (femmes ayant un IMVG à l'inclusion > 95 g/m2 ou hommes ayant un IMVG à l'inclusion > 115 g/m2) était de -18,6 (IC
English: c.C666A or c.C666G
French: c.C666A ou c.C666G
English: c.486G>C or c.486G>T
French: c.486G>C ou c.486G>T
English: c.978G>C or c.978G>T
French: c.978G>C ou c.978G>T
English: Galafold is not recommended for use in patients with severe renal insufficiency, defined as estimated GFR less than 30 mL/min/1.73m
French: Galafold n'est pas recommandé chez les patients présentant une insuffisance rénale sévère définie par un DFG inférieur à 30 ml/min/1,73 m2 (voir rubrique 5.2).
English: c.T402G or c.T402A
French: c.T402G ou c.T402A
English: c.784T>A or c.784T>C
French: c.784T>A ou c.784T>C
English: c.T894G or c.T894A
French: c.T894G ou c.T894A
English: c.747C>G or c.747C>A
French: c.747C>G ou c.747C>A
English: c.G978C or c.G978T
French: c.G978C ou c.G978T
English: c.369T>G or c.369T>A
French: c.369T>G ou c.369T>A
English: c.720G>C or c.720G>T
French: c.720G>C ou c.720G>T
English: c.G720C or c.G720T
French: c.G720C ou c.G720T
English: Muscle spasms Myalgia
French: Spasmes musculaires Myalgies
English: c.894T>G or c.894T>A
French: c.894T>G ou c.894T>A
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat
French: Chaque gélule contient 123 mg de migalastat (chlorhydrate de migalastat).
English: c.729G>C or c.729G>T
French: c.729G>C ou c.729G>T
English: c.T784A or c.T784C
French: c.T784A ou c.T784C
English: c.936G>T or c.936G>C
French: c.936G>T ou c.936G>C
English: c.G772C or c.G772A
French: c.G772C ou c.G772A
English: c.G708C or c.G708T
French: c.G708C ou c.G708T
English: c.G729C or c.G729T
French: c.G729C ou c.G729T
English: c.G778C or c.G778A
French: c.G778C ou c.G778A
English: c.G678T or c.G678C
French: c.G678T ou c.G678C
English: c.T706C or c.T706A
French: c.T706C ou c.T706A
English: was -33.1 (CI:-60.9, -5.4; n=4).
French: (IC à 95 %: -60,9, -5,4 ; n = 4).
English: c.72G>C or c.72G>T
French: c.72G>C ou c.72G>T
English: c.677G>A or c.678G>A
French: c.677G>A ou c.678G>A
English: UNKNOWN (del Exon2_3?)
French: INCONNU (del Exon2_3?)
English: c.678G>T or c.678G>C
French: c.678G>T ou c.678G>C
English: c.402T>G or c.402T>A
French: c.402T>G ou c.402T>A
English: c.A886T or c.A886C
French: c.A886T ou c.A886C
English: c.648T>A or c.648T>G
French: c.648T>A ou c.648T>G
English: c.772G>C or c.772G>A
French: c.772G>C ou c.772G>A
English: c.868A>C or c.868A>T
French: c.868A>C ou c.868A>T
English: c.G785A or c.G786A
French: c.G785A ou c.G786A
English: c.778G>C or c.778G>A
French: c.778G>C ou c.778G>A
English: c.666C>A or c.666C>G
French: c.666C>A ou c.666C>G
English: c.G677A or c.G678A
French: c.G677A ou c.G678A
English: c.702T>G or c.702T>A
French: c.702T>G ou c.702T>A
English: c.T702G or c.T702A
French: c.T702G ou c.T702A
English: c.785G>A or c.786G>A
French: c.785G>A ou c.786G>A
English: c.963G>C or c.963G>T
French: c.963G>C ou c.963G>T
English: c.706T>C or c.706T>A
French: c.706T>C ou c.706T>A
English: c.886A>T or c.886A>C
French: c.886A>T ou c.886A>C
English: If you get any side effects, talk to your doctor, pharmacist, or nurse.
French: Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin ou à votre pharmacien.
English: Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m
French: Galafold n'est pas recommandé chez les patients atteints de la maladie de Fabry dont le DFG estimé est inférieur à 30 ml/min/1.73 m2 (voir rubrique 5.2).
English: c.786G>C or c.786G>T
French: c.786G>C ou c.786G>T
English: c.G786C or c.G786T
French: c.G786C ou c.G786T
English: Protein sequence change c.126G>A or c.126G>C or c.126G>T
French: c.126G>A ou c.126G>C ou c.126G>T
English: c.687T>A or c.687T>G
French: c.687T>A ou c.687T>G
English: c.667T>A or c.668G>C
French: c.667T>A ou c.668G>C
English: c.G72C or c.G72T
French: c.G72C ou c.G72T
English: Protein Sequence change c.290delC
French: Modification de la séquence d'une protéine c.946delG
English: The change from baseline to Month 18 in LVMi (g/m 2) in patients with left ventricular hypertrophy (females with baseline LVMi > 95 g/m and males with baseline LVMi > 115 g/m2) was -8.4 (95% CI: -15.7, 2.6; n=13) for migalastat and 4.5 (95% CI: -10.7, 18.4; n=5) for ERT. After 30 months treatment with Galafold, the mean change from baseline in LVMi was -3.8 (95% CI: -8.9, 1.3; n=28) and the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline was -10.0 (95% CI: -16.6, -3.3; n=10).
French: Au bout de 30 mois de traitement par Galafold, la variation moyenne par rapport à l'inclusion de l'IMVG était de -3,8 (IC à 95 %: -8,9, 1,3; n = 28) et la variation moyenne par rapport à l'inclusion de l'IMVG des patients présentant une hypertrophie ventriculaire gauche à l'inclusion était de -10,0 (IC à 95 %: -16,6, -3,3; n = 10).
English: c.A1023C or c.A1023T
French: c.1023A >C ou c.1023A>T c.A1023C ou c.A1023T
English: c.798T>A or c.798T>G
French: c.798T>A ou c.798T>G
English: Protein Sequence change p.T412Sfs*37
French: p.T412Sfs*37
English: c.T798A or c.T798G
French: c.T798A ou c.T798G
English: c.789T>A or c.789T>G
French: c.789T>A ou c.789T>G
English: c.T789A or c.T789G
French: c.T789A ou c.T789G
English: Galafold 123 mg hard capsules Migalastat
French: Galafold 123 mg, gélules Migalastat
English: While taking Galafold you should use effective birth control.
French: Vous devez utiliser un mode de contraception efficace pendant le traitement par Galafold.
English: Protein Sequence change c.744delT
French: Modification de la séquence d'une protéine c.646dupT
English: • Shortness of breath
French: • Difficulté respiratoire (dyspnée)
English: Diarrhoea Nausea
French: Diarrhées
English: g.6547_9783del
French: INCONNU (del Exon3 et g.6547_9783del
English: DD month YYYY
French: DATE DE MISE À JOUR DU TEXTE JJ mois AAAA
English: Amicus Therapeutics Europe Limited
French: NOM DU TITULAIRE DE L'AUTORISATION DE MISE SUR LE MARCHÉ Amicus Therapeutics Europe Limited
English: BLISTER SLEEVE
French: Éruption cutanée Prurit
English: Rash Pruritus
French: Fonction rénale
English: • Painful stiff neck
French: • Nuque raide et douloureuse (torticolis)
English: Patients randomised to placebo in Stage 1 and switched to Galafold at month 6 (Stage 2) also demonstrated statistically significant decreases in interstitial capillary GL-3 inclusions at month 12 (-0.33±0.15; -58%) (p=0.014).
French: Au 12ème mois, les patients randomisés pour recevoir le placebo dans la phase I et qui étaient passés sous Galafold au 6ème mois (phase II) ont également montré des réductions statistiquement significatives des inclusions de
English: Titanium dioxide (E171) Indigotine (E132)
French: DONNÉES PHARMACEUTIQUES 6.1 Liste des excipients Contenu de la gélule Amidon prégélatinisé (maïs) Stéarate de magnésium Enveloppe de la gélule Gélatine Dioxyde de titane (E171) Indigotine (E132) Encre de marquage Gomme-laque Oxyde de fer noir Hydroxyde de potassium 6.2 Incompatibilités Sans objet.
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
French: Des informations sur Halimatoz sont disponibles sur le site web de l'Agence, sous: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
French: Cela signifie qu'Halimatoz est fortement similaire à un autre médicament biologique (le «médicament de référence») déjà autorisé dans l'UE.
English: Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients.
French: Les effets secondaires rapportés avec Halimatoz sont soigneusement évalués et toutes les mesures nécessaires sont prises pour protéger les patients.
English: All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
French: Toutes ces données ont été considérées comme suffisantes pour conclure qu'Halimatoz se comportera de la même façon qu'Humira en termes d'efficacité et de sécurité dans ses utilisations approuvées.
English: The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Halimatoz and 63% with Humira.
French: Une réduction des symptômes d'au moins 75 % après 16 semaines de traitement a été observée chez 68 % des patients avec Halimatoz, contre 63 % des patients avec Humira.
English: The reference medicine for Halimatoz is Humira.
French: Le médicament de référence pour Halimatoz est Humira.
English: What measures are being taken to ensure the safe and effective use of Halimatoz?
French: Quelles sont les mesures prises pour assurer l'utilisation sûre et efficace d'Halimatoz?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Halimatoz have also been included in the summary of product characteristics and the package leaflet.
French: Les recommandations et les précautions à observer par les professionnels de santé et les patients pour assurer l'utilisation sûre et efficace d'Halimatoz ont également été incluses dans le résumé des caractéristiques du produit et dans la notice.
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
French: Comme pour tous les médicaments, les données sur l'utilisation d'Halimatoz sont surveillées en permanence.
English: Therefore, the Agency's view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised.
French: Par conséquent, l'Agence a estimé que, comme pour Humira, le bénéfice d'Halimatoz est supérieur au risque identifié, et peut être autorisé.
English: In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
French: En outre, Halimatoz était aussi efficace qu'Humira dans une étude menée sur 465 patients atteints de psoriasis en plaques modéré à sévère.
English: Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
French: Halimatoz est essentiellement utilisé chez l'adulte lorsque sa maladie est sévère, modérément sévère ou qu'elle s'aggrave, ou lorsque les patients ne peuvent pas utiliser d'autre traitement.
English: Halimatoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
French: Halimatoz est disponible sous la forme de solution injectable sous la peau en seringue ou en stylo prérempli et est généralement administré toutes les deux semaines.
English: Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
French: Comme d'autres médicaments de sa classe, Halimatoz peut affecter l'aptitude du système immunitaire à combattre les infections et le cancer, et des cas d'infections graves et de cancers du sang chez les patients traités par adalimumab ont été relevés.