{"id":9520,"date":"2019-05-12T22:42:09","date_gmt":"2019-05-12T15:42:09","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=9520"},"modified":"2019-05-14T22:53:13","modified_gmt":"2019-05-14T15:53:13","slug":"ema-danh-gia-tinh-an-toan-cua-thuoc-dieu-tri-da-xo-cung-lemtrada","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/ema-danh-gia-tinh-an-toan-cua-thuoc-dieu-tri-da-xo-cung-lemtrada\/","title":{"rendered":"EMA: \u0110\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n c\u1ee7a thu\u1ed1c \u0111i\u1ec1u tr\u1ecb \u0111a x\u01a1 c\u1ee9ng Lemtrada"},"content":{"rendered":"<p>EMA \u0111\u00e3 b\u1eaft \u0111\u1ea7u \u0111\u00e1nh gi\u00e1 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb \u0111a x\u01a1 c\u1ee9ng <strong>Lemtrada<\/strong> (alemtuzumab) sau c\u00e1c b\u00e1o c\u00e1o m\u1edbi v\u1ec1 c\u00e1c b\u1ec7nh t\u1ef1 mi\u1ec5n (h\u1ec7 mi\u1ec5n d\u1ecbch c\u1ee7a c\u01a1 th\u1ec3 kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang c\u00e1ch) v\u00e0 c\u00e1c v\u1ea5n \u0111\u1ec1 v\u1ec1 tim v\u00e0 m\u1ea1ch m\u00e1u do thu\u1ed1c c\u0169ng nh\u01b0 c\u00e1c tr\u01b0\u1eddng h\u1ee3p t\u1eed vong c\u00f3 li\u00ean quan.<\/p>\n<p>Trong khi qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 \u0111ang di\u1ec5n ra, Lemtrada ch\u1ec9 n\u00ean \u0111\u01b0\u1ee3c kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb \u1edf ng\u01b0\u1eddi l\u1edbn m\u1eafc \u0111a x\u01a1 c\u1ee9ng t\u00e1i ph\u00e1t kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c b\u1eb1ng \u00edt nh\u1ea5t hai thu\u1ed1c \u0111i\u1ec1u tr\u1ecb t\u00e1c d\u1ee5ng ch\u1eadm ho\u1eb7c c\u00e1c li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb t\u00e1c d\u1ee5ng ch\u1eadm kh\u00e1c kh\u00f4ng s\u1eed d\u1ee5ng \u0111\u01b0\u1ee3c. B\u1ec7nh nh\u00e2n \u0111ang \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Lemtrada n\u1ebfu c\u00f3 ti\u1ebfn tri\u1ec3n t\u1ed1t c\u00f3 th\u1ec3 ti\u1ebfp t\u1ee5c \u0111i\u1ec1u tr\u1ecb d\u01b0\u1edbi s\u1ef1 t\u01b0 v\u1ea5n c\u1ee7a b\u00e1c s\u0129.<\/p>\n<h2>Ngo\u00e0i c\u00e1c h\u1ea1n ch\u1ebf, PRAC \u0111\u00e3 khuy\u1ebfn ngh\u1ecb c\u1eadp nh\u1eadt th\u00f4ng tin s\u1ea3n ph\u1ea9m cho Lemtrada \u0111\u1ec3 th\u00f4ng b\u00e1o cho b\u1ec7nh nh\u00e2n v\u00e0 c\u00e1c c\u00e1n b\u1ed9 y t\u1ebf v\u1ec1 c\u00e1c tr\u01b0\u1eddng h\u1ee3p:<\/h2>\n<ul>\n<li>C\u00e1c b\u1ec7nh t\u1ef1 mi\u1ec5n qua trung gian t\u1ebf b\u00e0o, bao g\u1ed3m vi\u00eam gan t\u1ef1 mi\u1ec5n v\u00e0 h\u1ed9i ch\u1ee9ng th\u1ef1c b\u00e0o t\u1ebf b\u00e0o m\u00e1u (ho\u1ea1t \u0111\u1ed9ng qu\u00e1 m\u1ee9c c\u1ee7a h\u1ec7 th\u1ed1ng mi\u1ec5n d\u1ecbch c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn nhi\u1ec1u b\u1ed9 ph\u1eadn trong c\u01a1 th\u1ec3);<\/li>\n<li>C\u00e1c v\u1ea5n \u0111\u1ec1 tr\u00ean tim v\u00e0 m\u1ea1ch m\u00e1u x\u1ea3y ra trong v\u00f2ng 1-3 ng\u00e0y k\u1ec3 t\u1eeb khi b\u1eaft \u0111\u1ea7u d\u00f9ng thu\u1ed1c, bao g\u1ed3m xung huy\u1ebft ph\u1ed5i, \u0111au tim, \u0111\u1ed9t qu\u1ef5, b\u00f3c t\u00e1ch \u0111\u1ed9ng m\u1ea1ch c\u1ed5 t\u1eed cung.<\/li>\n<li>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh nghi\u00eam tr\u1ecdng. C\u00e1c c\u00e1n b\u1ed9 y t\u1ebf n\u00ean xem x\u00e9t ng\u1eebng \u0111i\u1ec1u tr\u1ecb \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n xu\u1ea5t hi\u1ec7n c\u00e1c d\u1ea5u hi\u1ec7u n\u00e0yv\u00e0 b\u1ec7nh nh\u00e2n n\u00ean ngay l\u1eadp t\u1ee9c li\u00ean h\u1ec7 tr\u1ee3 gi\u00fap y t\u1ebf n\u1ebfu h\u1ecd g\u1eb7p c\u00e1c tri\u1ec7u ch\u1ee9ng tr\u00ean<\/li>\n<\/ul>\n<p>EMA hi\u1ec7n s\u1ebd \u0111\u00e1nh gi\u00e1 t\u1ea5t c\u1ea3 c\u00e1c d\u1eef li\u1ec7u c\u00f3 s\u1eb5n v\u1ec1 c\u00e1c v\u1ea5n \u0111\u1ec1 an to\u00e0n v\u1edbi thu\u1ed1c v\u00e0 xem x\u00e9t b\u1ea5t k\u1ef3 bi\u1ec7n ph\u00e1p b\u1ed5 sung n\u00e0o c\u1ea7n thi\u1ebft \u0111\u1ec3 b\u1ea3o v\u1ec7 b\u1ec7nh nh\u00e2n v\u00e0 li\u1ec7u c\u00f3 n\u00ean thay \u0111\u1ed5i ch\u1ec9 \u0111\u1ecbnh \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t hay kh\u00f4ng.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9522 aligncenter\" src=\"https:\/\/www.vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Lemtrada.jpg\" alt=\"Lemtrada\" width=\"450\" height=\"450\" title=\"\" srcset=\"https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Lemtrada.jpg 450w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Lemtrada-280x280.jpg 280w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Lemtrada-400x400.jpg 400w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Lemtrada-350x350.jpg 350w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Lemtrada-100x100.jpg 100w\" sizes=\"auto, (max-width: 450px) 100vw, 450px\" \/><\/p>\n<h2>Th\u00f4ng tin cho b\u1ec7nh nh\u00e2n<\/h2>\n<p>\u2022 C\u00e1c tr\u01b0\u1eddng h\u1ee3p m\u1edbi v\u1ec1 t\u00e1c d\u1ee5ng ph\u1ee5 c\u1ee7a Lemtrada \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o,bao g\u1ed3m c\u00e1c \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn tim, m\u1ea1ch m\u00e1u, ph\u1ed5i v\u00e0 gan.<\/p>\n<p>B\u1ec7nh nh\u00e2n c\u1ea7n \u0111\u01b0\u1ee3c h\u1ed7 tr\u1ee3 y t\u1ebf ngay l\u1eadp t\u1ee9c n\u1ebfu g\u1eb7p ph\u1ea3i c\u00e1c tri\u1ec7u ch\u1ee9ng sau:<\/p>\n<ul>\n<li>C\u00e1c b\u1ec7nh tim c\u1ea5p t\u00ednh (th\u01b0\u1eddng trong v\u00f2ng 1 \u0111\u1ebfn 3 ng\u00e0y k\u1ec3 t\u1eeb khi b\u1eaft \u0111\u1ea7u d\u00f9ng thu\u1ed1c): ch\u1eb3ng h\u1ea1n nh\u01b0 kh\u00f3 th\u1edf v\u00e0 \u0111au ng\u1ef1c.<\/li>\n<li>Xung huy\u1ebft ph\u1ed5i: kh\u00f3 th\u1edf v\u00e0 ho ra m\u00e1u.<\/li>\n<li>\u0110\u1ed9t qu\u1ef5 v\u00e0 \u0111\u1ee9t r\u00e1ch m\u1ea1ch m\u00e1u n\u00e3o: nh\u1ee9c \u0111\u1ea7u d\u1eef d\u1ed9i \u0111\u1ed9t ng\u1ed9t, \u0111au y\u1ebfu n\u1eeda ng\u01b0\u1eddi, kh\u00f3 n\u00f3i ho\u1eb7c \u0111au c\u1ed5.<\/li>\n<li>C\u00e1c v\u1ea5n \u0111\u1ec1 v\u1ec1 gan: v\u00e0ng da ho\u1eb7cv\u00e0ngm\u1eaft, n\u01b0\u1edbc ti\u1ec3u s\u1eabm m\u00e0u, d\u1ec5 ch\u1ea3y m\u00e1u v\u00e0 b\u1ea7m t\u00edm h\u01a1n b\u00ecnh th\u01b0\u1eddng.<\/li>\n<li>H\u1ed9i ch\u1ee9ng th\u1ef1c b\u00e0o t\u1ebf b\u00e0o m\u00e1u: s\u1ed1t, s\u01b0ng h\u1ea1ch, b\u1ea7m t\u00edm v\u00e0 ph\u00e1t ban da.<\/li>\n<\/ul>\n<p>\u2022 B\u00e1c s\u0129 n\u00ean ti\u1ebfn h\u00e0nh ki\u1ec3m tra khi b\u1ec7nh nh\u00e2n m\u1eafc ph\u1ea3i c\u00e1c tri\u1ec7u ch\u1ee9ng tr\u00ean v\u00e0 xem x\u00e9t ng\u01b0ng thu\u1ed1c Lemtrada v\u00e0 \u0111\u1ed5i sang c\u00e1c lo\u1ea1i thu\u1ed1c kh\u00e1c.<\/p>\n<p>\u2022 M\u1ed9t \u0111\u00e1nh gi\u00e1 chuy\u00ean s\u00e2u v\u1ec1 Lemtrada \u0111ang \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh v\u00e0 s\u1ebd c\u00f3 th\u00f4ng b\u00e1o ngay khi ph\u00e1t hi\u1ec7n ra th\u00eam th\u00f4ng tin m\u1edbi..<\/p>\n<p>\u2022 Trong khi vi\u1ec7c \u0111\u00e1nh gi\u00e1 \u0111ang di\u1ec5n ra, Lemtrada s\u1ebd ch\u1ec9 \u0111\u01b0\u1ee3c k\u00ea \u0111\u01a1n cho b\u1ec7nh nh\u00e2n m\u1edbi n\u1ebfu c\u00e1c lo\u1ea1i thu\u1ed1c kh\u00e1c kh\u00f4ng c\u00f3 t\u00e1c d\u1ee5ng ho\u1eb7c kh\u00f4ng ph\u00f9 h\u1ee3pv\u1edbi b\u1ec7nh nh\u00e2n<\/p>\n<p>\u2022 Tham kh\u1ea3o \u00fd ki\u1ebfn b\u00e1c s\u0129 n\u1ebfu c\u00f3 b\u1ea5t k\u00ec th\u1eafc m\u1eafc hay lo ng\u1ea1i n\u00e0o v\u1ec1 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb.<\/p>\n<h2>Th\u00f4ng tin cho c\u00e1n b\u1ed9 y t\u1ebf<\/h2>\n<p>\u2022 C\u00e1c b\u00e1c s\u0129 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o b\u1eb1ng v\u0103n b\u1ea3n v\u1ec1 c\u00e1c h\u1ea1n ch\u1ebf t\u1ea1m th\u1eddi \u0111\u1ed1i v\u1edbi ch\u1ec9 \u0111\u1ecbnh c\u1ee7a Lemtrada trong khi ch\u1edd k\u1ebft lu\u1eadn c\u1ee7a cu\u1ed9c \u0111\u00e1nh gi\u00e1 thu\u1ed1c \u0111ang \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh v\u00e0c\u00e1c c\u1ea3nh b\u00e1o an to\u00e0n m\u1edbi \u0111\u01b0\u1ee3c th\u00eam v\u00e0otrong th\u00f4ng tin s\u1ea3n ph\u1ea9m c\u1ee7a Lemtrada.<\/p>\n<p>\u2022 Thu\u1ed1c n\u00e0y ch\u1ec9 n\u00ean \u0111\u01b0\u1ee3c kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb\u1edf ng\u01b0\u1eddi l\u1edbn m\u1eafc b\u1ec7nh \u0111a x\u01a1 c\u1ee9ng t\u00e1i ph\u00e1t-thuy\u00ean gi\u1ea3m kh\u00f4ng \u0111\u00e1p \u1ee9ng v\u1edbi ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb \u0111\u00fang v\u00e0 \u0111\u1ee7 v\u1edbi \u00edt nh\u1ea5t hai thu\u1ed1c t\u00e1c d\u1ee5ng ch\u1eadm, ho\u1eb7c \u1edf b\u1ec7nh nh\u00e2n kh\u00f4ng \u0111\u00e1p \u1ee9ng ho\u1eb7c kh\u00f4ng s\u1eed d\u1ee5ng \u0111\u01b0\u1ee3c c\u00e1c thu\u1ed1c \u0111i\u1ec1u tr\u1ecb t\u00e1c d\u1ee5ng ch\u1eadm kh\u00e1c.<\/p>\n<p>\u2022 \u0110\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n \u0111ang \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Lemtrada, c\u1ea7n theo d\u00f5i c\u00e1c d\u1ea5u hi\u1ec7u sinh t\u1ed3n tr\u01b0\u1edbc v\u00e0 trong khi truy\u1ec1n t\u0129nh m\u1ea1ch. N\u1ebfu quan s\u00e1t th\u1ea5y nh\u1eefng thay \u0111\u1ed5i \u0111\u00e1ng k\u1ec3 v\u1ec1 m\u1eb7t l\u00e2m s\u00e0ng, n\u00ean xem x\u00e9tng\u1eebng truy\u1ec1n d\u1ecbch v\u00e0 theo d\u00f5i b\u1ed5 sung, bao g\u1ed3m c\u1ea3 ECG.<\/p>\n<p>\u2022 C\u00e1c x\u00e9t nghi\u1ec7m ch\u1ee9c n\u0103ng gan n\u00ean \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u01b0\u1edbc v\u00e0 trong khi \u0111i\u1ec1u tr\u1ecb. N\u1ebfu b\u1ec7nh nh\u00e2n c\u00f3 d\u1ea5u hi\u1ec7u t\u1ed5n th\u01b0\u01a1ng gan, t\u0103ng men gan kh\u00f4ng r\u00f5 nguy\u00ean nh\u00e2n ho\u1eb7c tri\u1ec7u ch\u1ee9ng li\u00ean quan \u0111\u1ebfn r\u1ed1i lo\u1ea1n ch\u1ee9c n\u0103ng gan ( bu\u1ed3n n\u00f4n kh\u00f4ng r\u00f5 nguy\u00ean nh\u00e2n, n\u00f4n, \u0111au b\u1ee5ng, m\u1ec7t m\u1ecfi, ch\u00e1n \u0103n, v\u00e0ng da ho\u1eb7c n\u01b0\u1edbc ti\u1ec3u s\u1eabm m\u00e0u), n\u00ean c\u00e2n nh\u1eafc l\u1ea1i vi\u1ec7c ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng Lemtrada.<\/p>\n<p>\u2022 B\u1ec7nh nh\u00e2n xu\u1ea5t hi\u1ec7n c\u00e1c d\u1ea5u hi\u1ec7uc\u1ee7a c\u00e1c b\u1ec7nh l\u00fd dok\u00edch ho\u1ea1t mi\u1ec5n d\u1ecbch n\u00ean \u0111\u01b0\u1ee3c theo d\u00f5i ngay l\u1eadp t\u1ee9c v\u00e0 xem x\u00e9t ch\u1ea9n \u0111o\u00e1n h\u1ed9i ch\u1ee9ng th\u1ef1c b\u00e0o t\u1ebf b\u00e0o m\u00e1u. C\u00e1c tri\u1ec7u ch\u1ee9ng do k\u00edch ho\u1ea1t mi\u1ec5n d\u1ecbch c\u00f3 th\u1ec3 x\u1ea3y ra mu\u1ed9n nh\u1ea5t 4 n\u0103m sau khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>\u2022 Th\u00f4ng tin th\u00eam s\u1ebd \u0111\u01b0\u1ee3c cung c\u1ea5p sau khi \u0111\u00e1nh gi\u00e1 Lemtrada \u0111\u01b0\u1ee3c k\u1ebft th\u00fac.<\/p>\n<h2>Th\u00f4ng tin th\u00eam v\u1ec1 thu\u1ed1c<\/h2>\n<p>Lemtrada l\u00e0 m\u1ed9t lo\u1ea1i thu\u1ed1c d\u00f9ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh \u0111a x\u01a1 c\u1ee9ng t\u00e1i ph\u00e1t-thuy\u00ean gi\u1ea3m, m\u1ed9t b\u1ec7nh l\u00fd d\u00e2y th\u1ea7n kinh trong \u0111\u00f3 ph\u1ea3n \u1ee9ngvi\u00eam ph\u00e1 h\u1ee7y v\u1ecf b\u1ecdc b\u1ea3o v\u1ec7 xung quanh c\u00e1c t\u1ebf b\u00e0o th\u1ea7n kinh. T\u00e1i ph\u00e1t \u2013 thuy\u00ean gi\u1ea3m c\u00f3 ngh\u0129a l\u00e0 b\u1ec7nh nh\u00e2n m\u1eafc c\u00e1c c\u01a1n \u0111a x\u01a1 c\u1ee9ng (t\u00e1i ph\u00e1t) xen k\u1ebd c\u00e1c kho\u1ea3ng th\u1eddi gian c\u00f3\u00edt ho\u1eb7c kh\u00f4ng c\u00f3 tri\u1ec7u ch\u1ee9ng (thuy\u00ean gi\u1ea3m). Thu\u1ed1c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho b\u1ec7nh nh\u00e2n \u0111ang m\u1eafc c\u00e1c c\u01a1n c\u1ea5p t\u00ednh. Thu\u1ed1c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng theo \u0111\u01b0\u1eddng truy\u1ec1n t\u0129nh m\u1ea1ch.<\/p>\n<p>Ho\u1ea1t ch\u1ea5t trong Lemtrada, alemtuzumab, l\u00e0 m\u1ed9t kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng (m\u1ed9t lo\u1ea1i protein) \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 nh\u1eadn bi\u1ebft v\u00e0 g\u1eafn v\u00e0o m\u1ed9t protein c\u00f3 t\u00ean CD52 \u0111\u01b0\u1ee3c t\u00ecm th\u1ea5y tr\u00ean c\u00e1c t\u1ebf b\u00e0o b\u1ea1ch c\u1ea7u c\u1ee7a h\u1ec7 th\u1ed1ng mi\u1ec5n d\u1ecbch . B\u1eb1ng c\u00e1ch g\u1eafn v\u00e0o CD52, alemtuzumab l\u00e0m cho c\u00e1c t\u1ebf b\u00e0o b\u1ea1ch c\u1ea7u b\u1ecb ch\u1ebft v\u00e0 \u0111\u01b0\u1ee3c thay th\u1ebf, do \u0111\u00f3 l\u00e0m gi\u1ea3m ho\u1ea1t \u0111\u1ed9ng g\u00e2y t\u1ed5n h\u1ea1i c\u1ee7a h\u1ec7 th\u1ed1ng mi\u1ec5n d\u1ecbch.<\/p>\n<h2>Th\u00f4ng tin th\u00eam v\u1ec1 cu\u1ed9c \u0111\u00e1nh gi\u00e1<\/h2>\n<p>Vi\u1ec7c xem x\u00e9t Lemtrada \u0111\u00e3 \u0111\u01b0\u1ee3c b\u1eaft \u0111\u1ea7u theo y\u00eau c\u1ea7u c\u1ee7a \u1ee6y ban Ch\u00e2u \u00c2u, theo \u0110i\u1ec1u 20 c\u1ee7a Quy \u0111\u1ecbnh (EC) s\u1ed1 726\/2004.<\/p>\n<p>Vi\u1ec7c xem x\u00e9t \u0111ang \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi \u1ee6y ban \u0111\u00e1nh gi\u00e1 r\u1ee7i ro c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c (PRAC), \u1ee6y ban ch\u1ecbu tr\u00e1ch nhi\u1ec7m \u0111\u00e1nh gi\u00e1 c\u00e1c v\u1ea5n \u0111\u1ec1 an to\u00e0n \u0111\u1ed1i v\u1edbi c\u00e1c thu\u1ed1c s\u1eed d\u1ee5ng \u1edf ng\u01b0\u1eddi, s\u1ebd \u0111\u01b0a ra m\u1ed9t lo\u1ea1t c\u00e1c khuy\u1ebfn ngh\u1ecb.<\/p>\n<p>Khi b\u1eaft \u0111\u1ea7u \u0111\u00e1nh gi\u00e1, PRAC \u0111\u00e3 \u0111\u01b0a ra c\u00e1c khuy\u1ebfn ngh\u1ecb t\u1ea1m th\u1eddi \u0111\u1ec3 h\u1ea1n ch\u1ebf vi\u1ec7c s\u1eed d\u1ee5ng Lemtrada \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n m\u1edbi. PRAC c\u0169ng \u0111\u00e3 \u0111\u01b0a ra c\u00e1c khuy\u1ebfn ngh\u1ecb \u0111\u1ec3 c\u1eadp nh\u1eadt th\u00f4ng tin s\u1ea3n ph\u1ea9m sau gi\u00e1m s\u00e1t an to\u00e0n .<\/p>\n<p>C\u00e1c khuy\u1ebfn ngh\u1ecb cu\u1ed1i c\u00f9ng c\u1ee7a PRAC s\u1ebd \u0111\u01b0\u1ee3c chuy\u1ec3n \u0111\u1ebfn CHMP. Giai \u0111o\u1ea1n cu\u1ed1i c\u00f9ng c\u1ee7a th\u1ee7 t\u1ee5c xem x\u00e9t l\u00e0 vi\u1ec7c \u1ee6y ban Ch\u00e2u \u00c2u th\u00f4ng qua quy\u1ebft \u0111\u1ecbnh r\u00e0ng bu\u1ed9c v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd \u00e1p d\u1ee5ng \u1edf t\u1ea5t c\u1ea3 c\u00e1c qu\u1ed1c gia th\u00e0nh vi\u00ean EU.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/lemtrada-article-20-referral-use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/lemtrada-article-20-referral-use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review_en.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMA \u0111\u00e3 b\u1eaft \u0111\u1ea7u \u0111\u00e1nh gi\u00e1 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb \u0111a x\u01a1 c\u1ee9ng Lemtrada (alemtuzumab) sau c\u00e1c b\u00e1o c\u00e1o m\u1edbi v\u1ec1 c\u00e1c b\u1ec7nh t\u1ef1 mi\u1ec5n (h\u1ec7 mi\u1ec5n d\u1ecbch c\u1ee7a c\u01a1 th\u1ec3 kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang c\u00e1ch) v\u00e0 c\u00e1c v\u1ea5n \u0111\u1ec1 v\u1ec1 tim v\u00e0 m\u1ea1ch m\u00e1u do thu\u1ed1c c\u0169ng nh\u01b0 c\u00e1c tr\u01b0\u1eddng h\u1ee3p t\u1eed vong c\u00f3 li\u00ean [&#8230;]\n","protected":false},"author":1,"featured_media":9521,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9520","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/9520","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=9520"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/9520\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/9521"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=9520"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=9520"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=9520"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}