{"id":4685,"date":"2019-03-12T09:06:19","date_gmt":"2019-03-12T02:06:19","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4685"},"modified":"2019-04-13T09:43:45","modified_gmt":"2019-04-13T02:43:45","slug":"ema-diem-tin-dang-chu-y-trong-cuoc-hop-dinh-ky-cua-chmp-tu-ngay-25-28-02-2019","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/ema-diem-tin-dang-chu-y-trong-cuoc-hop-dinh-ky-cua-chmp-tu-ngay-25-28-02-2019\/","title":{"rendered":"EMA: \u0110i\u1ec3m tin \u0111\u00e1ng ch\u00fa \u00fd trong cu\u1ed9c h\u1ecdp \u0111\u1ecbnh k\u1ef3 c\u1ee7a CHMP t\u1eeb ng\u00e0y 25-28\/02\/2019"},"content":{"rendered":"<p>CHMP \u0111\u00e3 c\u00f3 m\u1ed9t s\u1ed1 quy\u1ebft \u0111\u1ecbnh qu\u1ea3n l\u00fd li\u00ean quan \u0111\u1ebfn c\u00e1c ch\u1ebf ph\u1ea9m Dectova (zanamivir), Pazenir (paclitaxel), Doxolipad (doxorubicin), Riarify (beclometasone dipropionate \/ formoterol fumarate dihydrate \/ glycopyrronium) v\u00e0 Trydonis (beclometasone dipropionate \/ formoterol fumarate dihydrate \/ glycopyrronium).<\/p>\n<h2>Dectova (zanamivir)<\/h2>\n<p>Ng\u00e0y 28\/02\/2019, CHMP \u0111\u00e3 th\u00f4ng qua m\u1ed9t \u00fd ki\u1ebfn \u200b\u200bt\u00edch c\u1ef1c, khuy\u1ebfn ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh cho s\u1ea3n ph\u1ea9m thu\u1ed1c Dectova, s\u1eed d\u1ee5ng trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u1eb7c bi\u1ec7t \u0111i\u1ec1u tr\u1ecb b\u1ec7nh c\u00fam c\u00f3 bi\u1ebfn ch\u1ee9ng v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng \u0111e d\u1ecda \u0111\u1ebfn t\u00ednh m\u1ea1ng. C\u00f4ng ty xin c\u1ea5p ph\u00e9pcho s\u1ea3n ph\u1ea9m thu\u1ed1c n\u00e0y l\u00e0 GlaxoSmithKline Trading Services Limited.<\/p>\n<p>Dectova \u0111\u01b0\u1ee3c b\u00e0o ch\u1ebf \u1edf d\u1ea1ng dung d\u1ecbch truy\u1ec1n 10 mg\/ml. Ho\u1ea1t ch\u1ea5t trong Dectova l\u00e0 zanamivir, ch\u1ea5t \u1ee9c ch\u1ebf neuraminidase \u1edf vi-r\u00fat c\u00fam (m\u00e3 ATC: J05AH01), m\u1ed9t lo\u1ea1i enzyme quan tr\u1ecdng \u0111\u1ec3 virus x\u00e2m nh\u1eadp v\u00e0o c\u00e1c t\u1ebf b\u00e0o ch\u01b0a b\u1ecb nhi\u1ec5m, gi\u1ea3i ph\u00f3ng v\u00e0 l\u00e2y lan virus m\u1edbi sau khi t\u1ebf b\u00e0o b\u1ecb nhi\u1ec5m b\u1ec7nh.<\/p>\n<p>Dectova mang l\u1ea1i hi\u1ec7u qu\u1ea3 nhanh ch\u00f3ng khi s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb tri\u1ec7u ch\u1ee9ng v\u00e0 gi\u00fap b\u1ec7nh nh\u00e2n h\u1ed3i ph\u1ee5c \u1edf c\u00e1c tr\u01b0\u1eddng h\u1ee3p m\u1eafc b\u1ec7nh c\u00fam c\u00f3 bi\u1ebfn ch\u1ee9ng v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng \u0111e d\u1ecda \u0111\u1ebfn t\u00ednh m\u1ea1ng. C\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 ph\u1ed5 bi\u1ebfn nh\u1ea5t l\u00e0 ti\u00eau ch\u1ea3y, men gan t\u0103ng, t\u1ed5n th\u01b0\u01a1ng t\u1ebf b\u00e0o gan v\u00e0 ph\u00e1t ban.<\/p>\n<h3>Ch\u1ec9 \u0111\u1ecbnh \u0111\u1ea7y \u0111\u1ee7 c\u1ee7a thu\u1ed1c:<\/h3>\n<p>Dectova \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb nhi\u1ec5m virut c\u00fam A ho\u1eb7c B c\u00f3 bi\u1ebfn ch\u1ee9ng v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng \u0111e d\u1ecda t\u00ednh m\u1ea1ng \u1edf ng\u01b0\u1eddi l\u1edbn v\u00e0 tr\u1ebb em (tr\u00ean 6 th\u00e1ng tu\u1ed5i) khi:<\/p>\n<p>\u2022 Vi-r\u00fat c\u00fam b\u1ec7nh nh\u00e2n m\u1eafc ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh ho\u1eb7c nghi ng\u1edd kh\u00e1ng v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1ng c\u00fam kh\u00e1c v\u00e0 \/ ho\u1eb7c<\/p>\n<p>\u2022 C\u00e1c thu\u1ed1c kh\u00e1ng vi-r\u00fat kh\u00e1c \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u00fam, bao g\u1ed3m c\u1ea3 zanamivir d\u1ea1ng h\u00edt, kh\u00f4ng th\u00edch h\u1ee3p v\u1edbi b\u1ec7nh nh\u00e2n \u0111\u00f3.<\/p>\n<p>Dectova n\u00ean \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng theo t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn ch\u00ednh th\u1ed1ng.<\/p>\n<p>C\u00e1c khuy\u1ebfn ngh\u1ecb chi ti\u1ebft cho vi\u1ec7c s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong b\u1ea3n t\u00f3m t\u1eaft c\u00e1c \u0111\u1eb7c t\u00ednh c\u1ee7a s\u1ea3n ph\u1ea9m (SmPC), s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 trong b\u00e1o c\u00e1o \u0111\u00e1nh gi\u00e1 c\u00f4ng khai ch\u00e2u \u00c2u (EPAR) v\u00e0 \u0111\u01b0\u1ee3c cung c\u1ea5p b\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c ng\u00f4n ng\u1eef ch\u00ednh th\u1ee9c c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u sau khi \u1ee6y ban ch\u00e2u \u00c2u c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m n\u00e0y.<\/p>\n<h2>Pazenir (paclitaxel)<\/h2>\n<p>Ng\u00e0y 28\/02\/2019, CHMP \u0111\u00e3 th\u00f4ng qua m\u1ed9t \u00fd ki\u1ebfn \u200b\u200bt\u00edch c\u1ef1c, khuy\u1ebfn ngh\u1ecb c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh cho s\u1ea3n ph\u1ea9m thu\u1ed1c Pazenir, s\u1eed d\u1ee5ng trong \u0111i\u1ec1u tr\u1ecb ung th\u01b0 v\u00fa di c\u0103n v\u00e0 ung th\u01b0 ph\u1ed5i t\u1ebf b\u00e0o kh\u00f4ng nh\u1ecf.C\u00f4ng ty xin c\u1ea5p ph\u00e9p cho s\u1ea3n ph\u1ea9m thu\u1ed1c n\u00e0y l\u00e0 Teva B.V.<\/p>\n<p>Pazenir \u0111\u01b0\u1ee3c b\u00e0o ch\u1ebf d\u01b0\u1edbi d\u1ea1ng b\u1ed9t pha truy\u1ec1n 5mg\/ml. Ho\u1ea1t ch\u1ea5t c\u1ee7a Pazenir l\u00e0 paclitaxel, m\u1ed9t ch\u1ea5t ch\u1ed1ng ung th\u01b0 thu\u1ed9c nh\u00f3m taxanes (m\u00e3 ATC:L01CD01). Paclitaxel ng\u0103n ch\u1eb7n m\u1ed9t giai \u0111o\u1ea1n ph\u00e2n chia t\u1ebf b\u00e0o trong \u0111\u00f3 b\u1ed9 x\u01b0\u01a1ng b\u00ean trong t\u1ebf b\u00e0o \u0111\u01b0\u1ee3c th\u00e1o d\u1ee1 \u0111\u1ec3 cho ph\u00e9p t\u1ebf b\u00e0o ph\u00e2n chia. B\u1eb1ng c\u00e1ch gi\u1eef nguy\u00ean c\u1ea5u tr\u00fac n\u00e0y, c\u00e1c t\u1ebf b\u00e0o kh\u00f4ng th\u1ec3 ph\u00e2n chia v\u00e0 cu\u1ed1i c\u00f9ng ch\u00fang s\u1ebd ch\u1ebft. Pazenir c\u0169ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u00e1c t\u1ebf b\u00e0o kh\u00e1c nh\u01b0 t\u1ebf b\u00e0o m\u00e1u v\u00e0 t\u1ebf b\u00e0o th\u1ea7n kinh,n\u00ean c\u00f3 th\u1ec3 g\u00e2y ra c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5.<\/p>\n<p>Pazenir l\u00e0 m\u1ed9t lo\u1ea1i thu\u1ed1c generic c\u1ee7a Abraxane, m\u1ed9t lo\u1ea1i paclitaxel h\u1ea1t nano g\u1eafn v\u1edbi albumin kh\u00e1c, \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p t\u1ea1i EU t\u1eeb n\u0103m 2008. C\u00e1c nghi\u00ean c\u1ee9u \u0111\u00e3 ch\u1ee9ng minh ch\u1ea5t l\u01b0\u1ee3ng t\u01b0\u01a1ng x\u1ee9ng c\u1ee7a Pazenir.M\u1ed9t nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc gi\u1eefa hai s\u1ea3n ph\u1ea9m tr\u00ean \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n. \u0110i\u1ec1u n\u00e0y l\u00e0 do Pazenir \u0111\u01b0\u1ee3c truy\u1ec1n t\u0129nh m\u1ea1ch v\u00e0 c\u00e1c h\u1ea1t nano ph\u00e2n t\u00e1ch nhanh ch\u00f3ng, v\u00e0 c\u0169ng v\u00ec c\u00e1c th\u00e0nh ph\u1ea7n \u0111\u1ecbnh t\u00ednh v\u00e0 \u0111\u1ecbnhl\u01b0\u1ee3ng c\u0169ng nh\u01b0 b\u1ea3n ch\u1ea5t v\u00e0 \u0111\u1eb7c t\u00ednh c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m.<\/p>\n<h3>Ch\u1ec9 \u0111\u1ecbnh \u0111\u1ea7y \u0111\u1ee7 c\u1ee7a thu\u1ed1c:<\/h3>\n<p>Pazenir \u0111\u01a1n tr\u1ecb li\u1ec7u \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb ung th\u01b0 v\u00fa di c\u0103n \u1edf b\u1ec7nh nh\u00e2n th\u1ea5t b\u1ea1i v\u1edbi ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb \u0111\u1ea7u tay cho b\u1ec7nh di c\u0103n v\u00e0 \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ph\u00e1c \u0111\u1ed3 c\u00f3 anthracycline.<\/p>\n<p>Pazenir k\u1ebft h\u1ee3p v\u1edbi carboplatin \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb ung th\u01b0 ph\u1ed5i t\u1ebf b\u00e0o kh\u00f4ng nh\u1ecf \u1edf b\u1ec7nh nh\u00e2n kh\u00f4ng th\u1ec3 ph\u1eabu thu\u1eadt ho\u1eb7c x\u1ea1 tr\u1ecb.<\/p>\n<p>Pazenir ch\u1ec9 n\u00ean \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh d\u01b0\u1edbi s\u1ef1 gi\u00e1m s\u00e1t c\u1ee7a b\u00e1c s\u0129 chuy\u00ean khoa ung th\u01b0 c\u00f3 tr\u00ecnh \u0111\u1ed9 trong c\u00e1c c\u01a1 quan chuy\u00ean v\u1ec1 qu\u1ea3n l\u00fd c\u00e1c thu\u1ed1c g\u00e2y \u0111\u1ed9c t\u1ebf b\u00e0o.Thu\u1ed1ckh\u00f4ng n\u00ean \u0111\u01b0\u1ee3c thay th\u1ebf cho ho\u1eb7c k\u1ebft h\u1ee3p v\u1edbi c\u00e1c c\u00f4ng th\u1ee9c paclitaxel kh\u00e1c.<\/p>\n<p>C\u00e1c khuy\u1ebfn ngh\u1ecb chi ti\u1ebft cho vi\u1ec7c s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong b\u1ea3n t\u00f3m t\u1eaft c\u00e1c \u0111\u1eb7c t\u00ednh c\u1ee7a s\u1ea3n ph\u1ea9m (SmPC), s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 trong b\u00e1o c\u00e1o \u0111\u00e1nh gi\u00e1 c\u00f4ng khai ch\u00e2u \u00c2u (EPAR) v\u00e0 \u0111\u01b0\u1ee3c cung c\u1ea5p b\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c ng\u00f4n ng\u1eef ch\u00ednh th\u1ee9c c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u sau khi \u1ee6y ban ch\u00e2u \u00c2u c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m n\u00e0y.<\/p>\n<h2>T\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh Doxolipad (doxorubicin)<\/h2>\n<p>Ng\u00e0y 31\/01\/2019, CHMP \u0111\u00e3 th\u00f4ng qua m\u1ed9t \u00fd ki\u1ebfn \u200b\u200bti\u00eau c\u1ef1c, khuy\u1ebfn ngh\u1ecb t\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m thu\u1ed1c Doxolipad d\u00e0nh cho \u0111i\u1ec1u tr\u1ecb ung th\u01b0 v\u00fa v\u00e0 bu\u1ed3ng tr\u1ee9ng.<\/p>\n<p>C\u00f4ng ty xin c\u1ea5p ph\u00e9p l\u00e0 TLC Biopharmologistss B.V. C\u00f4ng ty c\u00f3 th\u1ec3 y\u00eau c\u1ea7u ki\u1ec3m tra l\u1ea1i \u00fd ki\u1ebfn \u200b\u200btrong v\u00f2ng 15 ng\u00e0y k\u1ec3 t\u1eeb khi nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o v\u1ec1 \u00fd ki\u1ebfn \u200b\u200bti\u00eau c\u1ef1c n\u00e0y.<\/p>\n<h3>Doxolipad l\u00e0 g\u00ec?<\/h3>\n<p>Doxolipad l\u00e0 m\u1ed9t lo\u1ea1i thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ung th\u01b0 c\u00f3 ch\u1ee9a ho\u1ea1t ch\u1ea5t doxorubicin. Thu\u1ed1c \u0111\u01b0\u1ee3c b\u00e0o ch\u1ebf d\u01b0\u1edbi d\u1ea1ng dung d\u1ecbch c\u00f4 \u0111\u1eb7c pha truy\u1ec1n t\u0129nh m\u1ea1ch.<\/p>\n<p>Doxolipad \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n nh\u01b0 1 thu\u1ed1c generic, c\u00f3 t\u00e1c d\u1ee5ng t\u01b0\u01a1ng \u0111\u01b0\u01a1ng thu\u1ed1c tham chi\u1ebfu Adriamycin \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh t\u1ea1i EU. S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa hai s\u1ea3n ph\u1ea9m tr\u00ean l\u00e0 \u1edf Doxolipad, ho\u1ea1t ch\u1ea5t doxorubicin \u0111\u01b0\u1ee3c bao b\u1ecdc b\u1edfi liposome.<\/p>\n<h3>Doxolipad d\u1ef1 ki\u1ebfn \u200b\u200bs\u1ebd \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 l\u00e0m g\u00ec?<\/h3>\n<p>Doxolipad d\u1ef1 ki\u1ebfn \u200b\u200bs\u1ebd \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb ung th\u01b0 v\u00fa di c\u0103n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 nguy c\u01a1 m\u1eafc c\u00e1c v\u1ea5n \u0111\u1ec1 v\u1ec1 tim v\u00e0 ung th\u01b0 bu\u1ed3ng tr\u1ee9ng \u1edf nh\u1eefng ph\u1ee5 n\u1eef kh\u00f4ng c\u00f2n \u0111\u00e1p \u1ee9ng v\u1edbi tr\u1ecb li\u1ec7u b\u1eb1ng ph\u00e1c \u0111\u1ed3 platinum.<\/p>\n<h3>Doxolipad ho\u1ea1t \u0111\u1ed9ng nh\u01b0 th\u1ebf n\u00e0o?<\/h3>\n<p>Ho\u1ea1t ch\u1ea5t trong Doxolipad, doxorubicin, l\u00e0 m\u1ed9t lo\u1ea1i thu\u1ed1c g\u00e2y \u0111\u1ed9c t\u1ebf b\u00e0o thu\u1ed9c nh\u00f3m \u2018anthracyclines\u2019. N\u00f3 ho\u1ea1t \u0111\u1ed9ng b\u1eb1ng c\u00e1ch can thi\u1ec7p v\u00e0o DNA trong c\u00e1c t\u1ebf b\u00e0o, ng\u0103n ch\u1eb7n qu\u00e1 tr\u00ecnh t\u00e1i b\u1ea3n DNA v\u00e0 t\u1ea1o protein. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 c\u00e1c t\u1ebf b\u00e0o ung th\u01b0 kh\u00f4ng th\u1ec3 ph\u00e2n chia v\u00e0 cu\u1ed1i c\u00f9ng ch\u00fang s\u1ebd ch\u1ebft.<\/p>\n<p>Doxorubicin b\u1eaft \u0111\u1ea7u \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u00e0o nh\u1eefng n\u0103m 1960s. Trong Doxolipad, ho\u1ea1t ch\u1ea5t n\u00e0y \u0111\u01b0\u1ee3c bao b\u1ecdc trong c\u00e1c liposome ng\u1ee5y trang (pegylated liposomes). C\u00e1c liposome l\u00e0m gi\u1ea3m t\u1ed1c \u0111\u1ed9 ph\u00e2n h\u1ee7y ho\u1ea1t ch\u1ea5t, cho ph\u00e9p n\u00f3 l\u01b0u th\u00f4ng trong m\u00e1u l\u00e2u h\u01a1n. Ch\u00fang c\u0169ng l\u00e0m gi\u1ea3m t\u00e1c d\u1ee5ng c\u1ee7a thu\u1ed1c tr\u00ean c\u00e1c t\u1ebf b\u00e0o kh\u00f4ng g\u00e2y ung th\u01b0, do \u0111\u00f3 \u00edt g\u00e2y ra t\u00e1c d\u1ee5ng ph\u1ee5.<\/p>\n<h3>\u00dd ki\u1ebfn c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t trong vi\u1ec7c xin c\u1ea5p ph\u00e9p<\/h3>\n<p>C\u00f4ng ty xin c\u1ea5p ph\u00e9p \u0111\u00e3 tr\u00ecnh b\u00e0y d\u1eef li\u1ec7u t\u1eeb c\u00e1c t\u00e0i li\u1ec7u khoa h\u1ecdc v\u00e0 d\u1eef li\u1ec7u t\u1eeb c\u00e1c nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong c\u00e1c m\u00f4 h\u00ecnh th\u1eed nghi\u1ec7m, bao g\u1ed3m so s\u00e1nh v\u1edbi m\u1ed9t lo\u1ea1i thu\u1ed1c doxorubicin \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p kh\u00e1c, Caelyx, c\u00f3 ch\u1ee9a doxorubicin \u1edf d\u1ea1ng liposome.<\/p>\n<p>Do Doxolipad \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n nh\u01b0 m\u1ed9t lo\u1ea1i thu\u1ed1c lai, c\u00f4ng ty c\u0169ng \u0111\u00e3 tr\u00ecnh b\u00e0y k\u1ebft qu\u1ea3 c\u1ee7a m\u1ed9t nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 \u0111i\u1ec1u tra xem li\u1ec7u s\u1ea3n ph\u1ea9m n\u00e0y c\u00f3 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc v\u1edbi Caelyx hay kh\u00f4ng. Hai lo\u1ea1i thu\u1ed1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc khi ch\u00fang c\u00f3 c\u00f9ng m\u1ed9t n\u1ed3ng \u0111\u1ed9 thu\u1ed1c \u1edf d\u1ea1ng ho\u1ea1t \u0111\u1ed9ng trong c\u01a1 th\u1ec3.<\/p>\n<p>M\u1eb7c d\u00f9 thu\u1ed1c tham chi\u1ebfu cho Doxolipad l\u00e0 Adriamycin, nh\u01b0ng thu\u1ed1c n\u00e0y kh\u00f4ng th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc v\u00ec n\u00f3 c\u00f3 ch\u1ee9a doxorubicin \u1edf d\u1ea1ng kh\u00e1c (kh\u00f4ng \u0111\u01b0\u1ee3c bao b\u1ecdc trong pegylated liposome). Do \u0111\u00f3, Caelyx \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng thay th\u1ebf.<\/p>\n<h3>C\u00e1c m\u1ed1i lo ng\u1ea1i ch\u00ednh c\u1ee7a CHMP \u0111\u00e3 d\u1eabn \u0111\u1ebfn s\u1ef1 t\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p l\u00e0 g\u00ec?<\/h3>\n<p>K\u1ebft qu\u1ea3 c\u1ee7a nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc cho th\u1ea5y Doxolipad c\u00f3 th\u1ec3 so s\u00e1nh v\u1edbi Caelyx v\u1ec1 l\u01b0\u1ee3ng doxorubicin b\u1ecdc trong liposome, nh\u01b0ng kh\u00f4ng cho th\u1ea5y l\u01b0\u1ee3ng doxorubicin t\u1ef1 do l\u00e0 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng gi\u1eefa hai lo\u1ea1i thu\u1ed1c.<\/p>\n<p>Do \u0111\u00f3, CHMP cho r\u1eb1ng kh\u00f4ng \u0111\u1ee7 b\u1eb1ng ch\u1ee9ng cho th\u1ea5y Doxolipad t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc v\u1edbi Caelyx, v\u00e0 kh\u00f4ng th\u1ec3 ch\u1ee9ng minh r\u1eb1ng l\u1ee3i \u00edch c\u1ee7a Doxolipad l\u1edbn h\u01a1n r\u1ee7i ro c\u1ee7a n\u00f3. Tr\u00ean c\u01a1 s\u1edf \u0111\u00f3, CHMP khuy\u1ebfn ngh\u1ecb t\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh Doxolipad.<\/p>\n<h3>\u1ea2nh h\u01b0\u1edfng c\u1ee7a vi\u1ec7c t\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p v\u1edbi b\u1ec7nh nh\u00e2n tham gia th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng<\/h3>\n<p>C\u00f4ng ty n\u00e0y \u0111\u00e3 th\u00f4ng b\u00e1o cho CHMP r\u1eb1ng kh\u00f4ng c\u00f3 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng Doxolipad n\u00e0o \u0111ang \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u1edf EU.<\/p>\n<p>Riarify (beclometasone dipropionate \/ formoterol fumarate dihydrate \/ glycopyrronium)<\/p>\n<p>Ng\u00e0y 28\/02\/2019,CHMP \u0111\u00e3 th\u00f4ng qua m\u1ed9t \u00fd ki\u1ebfn \u200b\u200bt\u00edch c\u1ef1c khuy\u1ebfn ngh\u1ecb thay \u0111\u1ed5i c\u00e1c \u0111i\u1ec1u kho\u1ea3n c\u1ee7a vi\u1ec7c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m thu\u1ed1c Riarify. Ch\u1ee7 s\u1edf h\u1eefu gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m thu\u1ed1c n\u00e0y l\u00e0 Chiesi Farmaceutici S.p.A.<\/p>\n<h3>CHMP \u0111\u00e3 ph\u00ea duy\u1ec7t ph\u1ea7n m\u1edf r\u1ed9ng cho ch\u1ec9 \u0111\u1ecbnh hi\u1ec7n c\u00f3 nh\u01b0 sau:<\/h3>\n<p>\u0110i\u1ec1u tr\u1ecb duy tr\u00ec \u1edf b\u1ec7nh nh\u00e2n m\u1eafc b\u1ec7nh ph\u1ed5i t\u1eafc ngh\u1ebdn m\u1ea1n t\u00ednh (COPD) m\u1ee9c \u0111\u1ed9 trung b\u00ecnh \u0111\u1ebfn n\u1eb7ng kh\u00f4ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb \u0111\u1ea7y \u0111\u1ee7 b\u1eb1ng s\u1ef1 k\u1ebft h\u1ee3p thu\u1ed1c corticosteroid d\u1ea1ng h\u00edt v\u00e0 thu\u1ed1c ch\u1ee7 v\u1eadn beta2 t\u00e1c d\u1ee5ng d\u00e0i ho\u1eb7c s\u1ef1 k\u1ebft h\u1ee3p thu\u1ed1c ch\u1ee7 v\u1eadn beta2 t\u00e1c d\u1ee5ng d\u00e0i v\u1edbi thu\u1ed1c \u0111\u1ed1i kh\u00e1ng muscarinic t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i.<\/p>\n<p>C\u00e1c khuy\u1ebfn ngh\u1ecb chi ti\u1ebft cho vi\u1ec7c s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong b\u1ea3n t\u00f3m t\u1eaft c\u00e1c \u0111\u1eb7c t\u00ednh c\u1ee7a s\u1ea3n ph\u1ea9m (SmPC), s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 trong b\u00e1o c\u00e1o \u0111\u00e1nh gi\u00e1 c\u00f4ng khai ch\u00e2u \u00c2u (EPAR) v\u00e0 \u0111\u01b0\u1ee3c cung c\u1ea5p b\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c ng\u00f4n ng\u1eef ch\u00ednh th\u1ee9c c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u sau khi \u1ee6y ban ch\u00e2u \u00c2u c\u00f4ng nh\u1eadn quy\u1ebft \u0111\u1ecbnh thay \u0111\u1ed5i vi\u1ec7c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m.<\/p>\n<h2>Trydonis (beclometasone dipropionate \/ formoterol fumarate dihydrate \/ glycopyrronium)<\/h2>\n<p>Ng\u00e0y 28\/02\/2019,CHMP \u0111\u00e3 th\u00f4ng qua m\u1ed9t \u00fd ki\u1ebfn \u200b\u200bt\u00edch c\u1ef1c khuy\u1ebfn ngh\u1ecb thay \u0111\u1ed5i c\u00e1c \u0111i\u1ec1u kho\u1ea3n c\u1ee7a vi\u1ec7c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m thu\u1ed1c Trydonis. Ch\u1ee7 s\u1edf h\u1eefu gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m thu\u1ed1c n\u00e0y l\u00e0 Chiesi Farmaceutici S.p.A.<\/p>\n<h3>CHMP \u0111\u00e3 ph\u00ea duy\u1ec7t ph\u1ea7n m\u1edf r\u1ed9ng cho ch\u1ec9 \u0111\u1ecbnh hi\u1ec7n c\u00f3 nh\u01b0 sau:<\/h3>\n<p>\u0110i\u1ec1u tr\u1ecb duy tr\u00ec \u1edf b\u1ec7nh nh\u00e2n m\u1eafc b\u1ec7nh ph\u1ed5i t\u1eafc ngh\u1ebdn m\u1ea1n t\u00ednh (COPD) m\u1ee9c \u0111\u1ed9 trung b\u00ecnh \u0111\u1ebfn n\u1eb7ng kh\u00f4ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb \u0111\u1ea7y \u0111\u1ee7 b\u1eb1ng s\u1ef1 k\u1ebft h\u1ee3p thu\u1ed1c corticosteroid d\u1ea1ng h\u00edt v\u00e0 thu\u1ed1c ch\u1ee7 v\u1eadn beta2 t\u00e1c d\u1ee5ng d\u00e0i ho\u1eb7c s\u1ef1 k\u1ebft h\u1ee3p thu\u1ed1c ch\u1ee7 v\u1eadn beta2 t\u00e1c d\u1ee5ng d\u00e0i v\u1edbi thu\u1ed1c \u0111\u1ed1i kh\u00e1ng muscarinic t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i.<\/p>\n<p>C\u00e1c khuy\u1ebfn ngh\u1ecb chi ti\u1ebft cho vi\u1ec7c s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong b\u1ea3n t\u00f3m t\u1eaft c\u00e1c \u0111\u1eb7c t\u00ednh c\u1ee7a s\u1ea3n ph\u1ea9m (SmPC), s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 trong b\u00e1o c\u00e1o \u0111\u00e1nh gi\u00e1 c\u00f4ng khai ch\u00e2u \u00c2u (EPAR) v\u00e0 \u0111\u01b0\u1ee3c cung c\u1ea5p b\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c ng\u00f4n ng\u1eef ch\u00ednh th\u1ee9c c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u sau khi \u1ee6y ban ch\u00e2u \u00c2u c\u00f4ng nh\u1eadn quy\u1ebft \u0111\u1ecbnh thay \u0111\u1ed5i vi\u1ec7c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-february-2019\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-february-2019<\/a><\/p>\n<p>Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: \u0110\u1ed7 Thu Thanh \u2013 Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay &#8211; Trung T\u00e2m C\u1ea3nh Gi\u00e1c D\u01b0\u1ee3c Qu\u1ed1c Gia.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>CHMP \u0111\u00e3 c\u00f3 m\u1ed9t s\u1ed1 quy\u1ebft \u0111\u1ecbnh qu\u1ea3n l\u00fd li\u00ean quan \u0111\u1ebfn c\u00e1c ch\u1ebf ph\u1ea9m Dectova (zanamivir), Pazenir (paclitaxel), Doxolipad (doxorubicin), Riarify (beclometasone dipropionate \/ formoterol fumarate dihydrate \/ glycopyrronium) v\u00e0 Trydonis (beclometasone dipropionate \/ formoterol fumarate dihydrate \/ glycopyrronium). Dectova (zanamivir) Ng\u00e0y 28\/02\/2019, CHMP \u0111\u00e3 th\u00f4ng qua m\u1ed9t \u00fd ki\u1ebfn \u200b\u200bt\u00edch c\u1ef1c, khuy\u1ebfn ngh\u1ecb [&#8230;]\n","protected":false},"author":1,"featured_media":4689,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4685","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\/4685","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=4685"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4685\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4689"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4685"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4685"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}