{"id":8817,"date":"2019-04-28T17:52:12","date_gmt":"2019-04-28T10:52:12","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=8817"},"modified":"2019-05-01T17:57:09","modified_gmt":"2019-05-01T10:57:09","slug":"tien-hanh-danh-gia-cac-san-pham-kem-boi-dung-tai-cho-chua-estradiol","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/tien-hanh-danh-gia-cac-san-pham-kem-boi-dung-tai-cho-chua-estradiol\/","title":{"rendered":"Ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 c\u00e1c s\u1ea3n ph\u1ea9m kem b\u00f4i d\u00f9ng t\u1ea1i ch\u1ed7 ch\u1ee9a Estradiol"},"content":{"rendered":"<h2>\u0110\u00e1nh gi\u00e1 m\u1edbi c\u1ee7a EMA v\u1ec1 nguy c\u01a1 c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m kem b\u00f4i ch\u1ee9a estradiol h\u00e0m l\u01b0\u1ee3ng cao<\/h2>\n<p>EMA \u0111\u00e3 b\u1eaft \u0111\u1ea7u m\u1ed9t \u0111\u00e1nh gi\u00e1 m\u1edbi v\u1ec1 c\u00e1c lo\u1ea1i kem c\u00f3 ch\u1ee9a estradiol h\u00e0m l\u01b0\u1ee3ng cao (0.01% w \/ w) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u01b0\u1eddng \u00e2m \u0111\u1ea1o \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb \u1edf ph\u1ee5 n\u1eef b\u1ecb teo \u00e2m \u0111\u1ea1o \u0111\u00e3 m\u00e3n kinh.<\/p>\n<p>\u0110\u00e1nh gi\u00e1 n\u00e0y l\u01b0\u1ee3ng gi\u00e1 nguy c\u01a1 estradiol trong c\u00e1c lo\u1ea1i kem n\u00e0y \u0111\u01b0\u1ee3c h\u1ea5p thu v\u00e0 g\u00e2y t\u00e1c d\u1ee5ng to\u00e0n th\u00e2n. H\u1ea5p thu to\u00e0n th\u00e2n l\u00e0 \u0111i\u1ec1u \u0111\u00e1ng quan t\u00e2m v\u00ec n\u00f3 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 t\u01b0\u01a1ng t\u1ef1 nh\u01b0 khi s\u1eed d\u1ee5ng estradiol trong li\u1ec7u ph\u00e1p thay th\u1ebf hormon \u0111\u01b0\u1eddng to\u00e0n th\u00e2n (HRT), bao g\u1ed3m huy\u1ebft kh\u1ed1i t\u0129nh m\u1ea1ch ,\u0111\u1ed9t qu\u1ef5 v\u00e0 ung th\u01b0 n\u1ed9i m\u1ea1c t\u1eed cung (ung th\u01b0 ni\u00eam m\u1ea1c t\u1eed cung).<\/p>\n<figure id=\"attachment_8818\" aria-describedby=\"caption-attachment-8818\" style=\"width: 450px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-8818\" src=\"https:\/\/www.vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Estradiol.jpg\" alt=\"Estradiol\" width=\"450\" height=\"450\" title=\"\" srcset=\"https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Estradiol.jpg 450w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Estradiol-280x280.jpg 280w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Estradiol-400x400.jpg 400w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Estradiol-350x350.jpg 350w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/05\/Estradiol-100x100.jpg 100w\" sizes=\"auto, (max-width: 450px) 100vw, 450px\" \/><figcaption id=\"caption-attachment-8818\" class=\"wp-caption-text\">H\u00ecnh \u1ea3nh: c\u00f4ng th\u1ee9c c\u1ea5u t\u1ea1o c\u1ee7a Estradiol<\/figcaption><\/figure>\n<p>V\u00e0o n\u0103m 2014, EMA \u0111\u00e3 ho\u00e0n th\u00e0nh \u0111\u00e1nh gi\u00e1 v\u1ec1 nguy c\u01a1 h\u1ea5p th\u1ee5 to\u00e0n th\u00e2n v\u1edbi c\u00e1c lo\u1ea1i kem b\u00f4i estradiol h\u00e0m l\u01b0\u1ee3ng cao v\u00e0 \u0111\u00e3 c\u00f3 nhi\u1ec1u bi\u1ec7n ph\u00e1p \u0111\u01b0\u1ee3c khuy\u1ebfn ngh\u1ecb \u0111\u1ec3 gi\u1ea3m thi\u1ec3u nguy c\u01a1 n\u00e0y, bao g\u1ed3m h\u1ea1n ch\u1ebf s\u1eed d\u1ee5ng kem trong th\u1eddi gian t\u1ed1i \u0111a 4 tu\u1ea7n. Tuy nhi\u00ean, v\u00e0o th\u00e1ng 3 n\u0103m 2019, T\u00f2a \u00e1n C\u00f4ng l\u00fd EU \u0111\u00e3 b\u00e3i b\u1ecf m\u1ed9t ph\u1ea7n k\u1ebft lu\u1eadn c\u1ee7a vi\u1ec7c xem x\u00e9t tr\u00ean c\u01a1 s\u1edf t\u1ed1 t\u1ee5ng. M\u1eb7c d\u00f9 T\u00f2a \u00e1n C\u00f4ng l\u00fd kh\u00f4ng \u0111\u1eb7t c\u00e2u h\u1ecfi v\u1ec1 k\u1ebft lu\u1eadn khoa h\u1ecdc, nh\u01b0ng vi\u1ec7c h\u1ee7y b\u1ecf m\u1ed9t ph\u1ea7n c\u00f3 ngh\u0129a l\u00e0 m\u1ed9t s\u1ed1 bi\u1ec7n ph\u00e1p \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 gi\u1ea3m thi\u1ec3u r\u1ee7i ro \u0111\u00e3 b\u1ecb v\u00f4 hi\u1ec7u h\u00f3a.<\/p>\n<p>Do \u0111\u00f3, \u1ee6y ban Ch\u00e2u \u00c2u (EC) \u0111\u00e3 y\u00eau c\u1ea7u EMA \u0111\u00e1nh gi\u00e1 l\u1ea1i r\u1ee7i ro n\u00e0y, c\u00f3 t\u00ednh \u0111\u1ebfn c\u1ea3 d\u1eef li\u1ec7u g\u1ed1c v\u00e0 b\u1ea5t k\u1ef3 d\u1eef li\u1ec7u m\u1edbi n\u00e0o c\u00f3 s\u1eb5n k\u1ec3 t\u1eeb \u0111\u00e1nh gi\u00e1 tr\u01b0\u1edbc \u0111\u00f3 v\u00e0 \u0111\u1ec1 xu\u1ea5t c\u00e1c bi\u1ec7n ph\u00e1p c\u1ea7n \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng \u0111\u1ec3 b\u1ea3o v\u1ec7 b\u1ec7nh nh\u00e2n. Vi\u1ec7c \u0111\u00e1nh gi\u00e1 s\u1ebd \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi PRAC.<\/p>\n<p>Trong khi \u0111\u00e1nh gi\u00e1 \u0111ang di\u1ec5n ra, nh\u1eefng ph\u1ee5 n\u1eef c\u00f3 b\u1ea5t k\u1ef3 th\u1eafc m\u1eafc ho\u1eb7c m\u1ed1i lo ng\u1ea1i n\u00e0o v\u1ec1 vi\u1ec7c \u0111i\u1ec1u tr\u1ecb v\u1edbi estradiol n\u00ean tham kh\u1ea3o \u00fd ki\u1ebfn c\u1ee7a b\u00e1c s\u0129 ho\u1eb7c d\u01b0\u1ee3c s\u0129.<\/p>\n<p>Nh\u1eefng lo\u1ea1i kem c\u00f3 ch\u1ee9a estradiol h\u00e0m l\u01b0\u1ee3ng cao n\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh t\u1ea1i EU \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb teo \u00e2m \u0111\u1ea1o \u1edf ph\u1ee5 n\u1eef sau m\u00e3n kinh trong h\u01a1n 40 n\u0103m. C\u00e1c thu\u1ed1c n\u00e0y \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh \u1edf \u00c1o, Bulgaria, Croatia, C\u1ed9ng h\u00f2a S\u00e9c, Estonia, \u0110\u1ee9c, Hungary, Latvia, Litva v\u00e0 Slovakia d\u01b0\u1edbi c\u00e1c t\u00ean th\u01b0\u01a1ng m\u1ea1i sau: Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff v\u00e0 Montadiol.<\/p>\n<h2>Th\u00f4ng tin th\u00eam v\u1ec1 \u0111\u00e1nh gi\u00e1<\/h2>\n<p>\u0110\u00e1nh gi\u00e1 c\u00e1c lo\u1ea1i kem c\u00f3 ch\u1ee9a estradiol h\u00e0m l\u01b0\u1ee3ng cao (0. 01% w \/ w) \u0111\u01b0\u1ee3c b\u1eaft \u0111\u1ea7u theo y\u00eau c\u1ea7u c\u1ee7a \u1ee6y ban Ch\u00e2u \u00c2u, theo \u0110i\u1ec1u 31 c\u1ee7a Ch\u1ec9 th\u1ecb 2001\/83 \/ EC.<\/p>\n<p>Cu\u1ed9c \u0111\u00e1nh gi\u00e1 \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). V\u00ec c\u00e1c lo\u1ea1i thu\u1ed1c n\u00e0y \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh tr\u00ean nhi\u1ec1u qu\u1ed1c gia trong l\u00e3nh th\u1ed5 Ch\u00e2u \u00c2u, c\u00e1c khuy\u1ebfn ngh\u1ecb c\u1ee7a PRAC s\u1ebd \u0111\u01b0\u1ee3c chuy\u1ec3n \u0111\u1ebfn CMDh.CMDh l\u00e0 m\u1ed9t c\u01a1 quan \u0111\u1ea1i di\u1ec7n cho c\u00e1c qu\u1ed1c gia th\u00e0nh vi\u00ean EU c\u0169ng nh\u01b0 Iceland, Liechtenstein v\u00e0 Na Uy. C\u01a1 quan n\u00e0y c\u00f3 tr\u00e1ch nhi\u1ec7m \u0111\u1ea3m b\u1ea3o c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n h\u00e0i h\u00f2a cho c\u00e1c lo\u1ea1i thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh th\u00f4ng qua c\u00e1c th\u1ee7 t\u1ee5c qu\u1ed1c gia tr\u00ean to\u00e0n EU.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/estradiol-containing-001-w\/w-medicinal-products-topical-use-article-31-referral-new-review-risks-high-strength-estradiol_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/estradiol-containing-001-w\/w-medicinal-products-topical-use-article-31-referral-new-review-risks-high-strength-estradiol_en.pdf<\/a><\/p>\n<p>Th\u00f4ng b\u00e1o cho ban th\u01b0 k\u00fd c\u1ee7a PRAC\/EMA theo \u0110i\u1ec1u 31 Ch\u1ec9 th\u1ecb 2001\/83\/EC<\/p>\n<p>Th\u00f4ng b\u00e1o n\u00e0y \u0111\u01b0\u1ee3c \u0111\u01b0\u1ee3c g\u1eedi t\u1edbi PRAC theo \u0110i\u1ec1u 31 Ch\u1ec9 t\u1ecb 2001\/83\/EC c\u1ee7a \u1ee6y ban Ch\u00e2u \u00c2u<\/p>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>T\u00ean s\u1ea3n ph\u1ea9m<\/td>\n<td>Kem b\u00f4i c\u00f3 ch\u1ee9a oestradiol (v\u00e0 c\u00e1c ho\u1ea1t ch\u1ea5t li\u00ean quan) h\u00e0m l\u01b0\u1ee3ng cao, s\u1eed d\u1ee5ng t\u1ea1i ch\u1ed7 (\u0111\u01b0\u1eddng \u00e2m \u0111\u1ea1o)<\/td>\n<\/tr>\n<tr>\n<td>Ho\u1ea1t ch\u1ea5t<\/td>\n<td>Oestradiol<\/td>\n<\/tr>\n<tr>\n<td>D\u1ea1ng b\u00e0o ch\u1ebf<\/td>\n<td>Kem\/S\u1eefa s\u1eed d\u1ee5ng t\u1ea1i ch\u1ed7 (\u00e2m \u0111\u1ea1o)<\/td>\n<\/tr>\n<tr>\n<td>H\u00e0m l\u01b0\u1ee3ng<\/td>\n<td>0.01% w\/w<\/td>\n<\/tr>\n<tr>\n<td>\u0110\u01b0\u1eddng d\u00f9ng<\/td>\n<td>T\u1ea1i ch\u1ed7 (\u0111\u01b0\u1eddng \u00e2m \u0111\u1ea1o)<\/td>\n<\/tr>\n<tr>\n<td>C\u00f4ng ty n\u1eafm quy\u1ec1n c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh<\/td>\n<td>Dr. August Wolff CmbH and Co. KG Arzneimittel<\/p>\n<p>Pharmazeutische Fabrik Montavit GesmbH<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Ng\u00e0y 25\/4\/2014, CHMP \u0111\u00e3 t\u1ed5ng k\u1ebft m\u1ed9t b\u00e0i \u0111\u00e1nh gi\u00e1 t\u1ed5ng quan v\u1ec1 c\u00e2n b\u1eb1ng gi\u1eefa l\u1ee3i \u00edch-nguy c\u01a1 khi s\u1eed d\u1ee5ng c\u00e1c s\u1ea3n ph\u1ea9m c\u00f3 ch\u1ee9a oestradiol h\u00e0m l\u01b0\u1ee3ng cao \u0111\u01b0\u1eddng d\u00f9ng t\u1ea1i ch\u1ed7 (b\u00ean trong \u00e2m \u0111\u1ea1o, tr\u00ean ni\u00eam m\u1ea1c \u00e2m h\u1ed9 v\u00e0 \u00e2m \u0111\u1ea1o) \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb teo \u00e2m \u0111\u1ea1o, theo \u0110i\u1ec1u 31 Ch\u1ec9 th\u1ecb 2001\/83\/EC.<\/p>\n<p>C\u00e1c s\u1ea3n ph\u1ea9m n\u00e0y \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng t\u1ea1i ch\u1ed7 \u0111\u1ec3 l\u00e0m gi\u1ea3m tri\u1ec7u ch\u1ee9ng c\u1ee7a b\u1ec7nh teo \u00e2m \u0111\u1ea1o \u1edf ph\u1ee5 n\u1eef sau m\u00e3n kinh.<\/p>\n<p>\u0110\u00e1nh gi\u00e1 n\u00e0y \u0111\u01b0\u1ee3c b\u1eaft \u0111\u1ea7u ti\u1ebfn h\u00e0nh sau khi m\u1ed9t s\u1ed1 d\u1eef li\u1ec7u cho th\u1ea5y n\u1ed3ng \u0111\u1ed9 cao oestradiol trong huy\u1ebft t\u01b0\u01a1ng sau khi ch\u1ec9 \u0111\u1ecbnh c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c ch\u1ee9a oestradiol h\u00e0m l\u01b0\u1ee3ng 0.01% w\/w (0.01g oestradiol trong 100g kem).<\/p>\n<p>V\u00e0o th\u1eddi \u0111i\u1ec3m \u0111\u00f3, nh\u1eadn th\u1ea5y ch\u1ebf \u0111\u1ed9 li\u1ec1u cao oestradiol v\u00e0 vi\u1ec7c ph\u01a1i nhi\u1ec5m to\u00e0n th\u00e2n v\u1edbi oestradiol h\u00e0m l\u01b0\u1ee3ng cao, CHMP lo ng\u1ea1i v\u1ec1 nh\u1eefng \u1ea3nh h\u01b0\u1edfng c\u1ee7a ph\u00e1t hi\u1ec7n m\u1edbi n\u00e0y \u0111\u1ebfn th\u00f4ng tin an to\u00e0n c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c s\u1eed d\u1ee5ng \u0111\u01b0\u1eddng \u00e2m \u0111\u1ea1o v\u00e0 \u0111\u00e3 ki\u1ebfn ngh\u1ecb c\u00e1c gi\u1ea3i ph\u00e1p sau:<\/p>\n<p>Thay \u0111\u1ed5i ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb teo \u00e2m \u0111\u1ea1o do suy gi\u1ea3m oestrogen \u1edf ph\u1ee5 n\u1eef sau m\u00e3n kinh<br \/>\nGi\u1edbi h\u1ea1n l\u1ea1i li\u1ec7u tr\u00ecnh \u0111i\u1ec1u tr\u1ecb (4 tu\u1ea7n)<br \/>\nC\u00e2n nh\u1eafc c\u00e1c li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb thay th\u1ebf trong tr\u01b0\u1eddng h\u1ee3p b\u1ec7nh t\u00e1i ph\u00e1t c\u0169ng nh\u01b0 c\u1eadp nh\u1eadt th\u00eam th\u00f4ng tin ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh v\u00e0 c\u1ea3nh b\u00e1o li\u00ean quan \u0111\u1ebfn c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 tr\u00ean to\u00e0n th\u00e2n c\u1ee7a oestradiol<br \/>\nThu h\u1ed3i c\u00e1c s\u1ea3n ph\u1ea9m ch\u1ee9a l\u01b0\u1ee3ng thu\u1ed1c l\u1edbn h\u01a1n 100g kem b\u00f4i kh\u1ecfi th\u1ecb tr\u01b0\u1eddng l\u01b0u h\u00e0nh.<br \/>\nH\u01a1n n\u1eefa, d\u1ef1a tr\u00ean c\u00e1c d\u1eef li\u1ec7u c\u00f3 s\u1eb5n v\u1ec1 hi\u1ec7u qu\u1ea3 c\u1ee7a thu\u1ed1c, CHMP khuy\u1ebfn c\u00e1o vi\u1ec7c gi\u1edbi h\u1ea1n l\u1ea1i ch\u1ec9 \u0111\u1ecbnh c\u1ee7a c\u00e1c thu\u1ed1c \u0111i\u1ec1u tr\u1ecb teo \u00e2m \u0111\u1ea1o do suy gi\u1ea3m oestrogen \u1edf ph\u1ee5 n\u1eef sau m\u00e3n kinh: ch\u1ec9 s\u1eed d\u1ee5ng theo \u0111\u01b0\u1eddng \u00e2m \u0111\u1ea1o, kh\u00f4ng b\u00f4i tr\u00ean c\u00e1c khu v\u1ef1c kh\u00e1c ngo\u00e0i c\u01a1 quan sinh d\u1ee5c.<\/p>\n<p>Vi\u1ec7c h\u1ee7y b\u1ecf m\u1ed9t ph\u1ea7n quy\u1ebft \u0111\u1ecbnh c\u1ee7a \u1ee6y ban d\u1eabn \u0111\u1ebfn s\u1ef1 v\u00f4 hi\u1ec7u h\u00f3a c\u1ee7a m\u1ed9t s\u1ed1 bi\u1ec7n ph\u00e1p h\u1ea1n ch\u1ebf \u0111\u01b0\u1ee3c \u0111\u01b0a ra nh\u01b0 l\u00e0 k\u1ebft q\u1ee7a c\u1ee7a c\u00e1c cu\u1ed9c \u0111\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 \u1edf tr\u00ean, ngay c\u1ea3 khi \u0111\u00e1nh gi\u00e1 khoa h\u1ecdc v\u1ec1 c\u00e1c s\u1ea3n ph\u1ea9m kh\u00f4ng b\u1ecb T\u00f2a \u00e1n \u0111\u01b0a ra ph\u00e1n quy\u1ebft.<\/p>\n<p>\u1ee6y ban Ch\u00e2u \u00c2u sau \u0111\u00f3 \u0111\u00e3 lo ng\u1ea1i v\u1ec1 c\u00e1c nguy c\u01a1 an to\u00e0n \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh. C\u00e1c s\u1ea3n ph\u1ea9m tr\u00ean kh\u00f4ng c\u00f2n ph\u00f9 h\u1ee3p v\u1edbi ch\u1ecb \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb v\u00e0 c\u00e1c b\u1ec7nh nh\u00e2n n\u1eef ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi nhi\u1ec1u nguy c\u01a1 khi s\u1eed d\u1ee5ng c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u00f3.<\/p>\n<p>Do \u0111\u00f3, vi\u1ec7c \u0111\u00e1nh gi\u00e1 l\u1ea1i c\u00e1c s\u1ea3n ph\u1ea9m tr\u00ean theo \u0110i\u1ec1u 31 Ch\u1ec9 th\u1ecb 2001\/83\/EC l\u00e0 r\u1ea5t c\u1ea7n thi\u1ebft. M\u1ed9t \u0111\u00e1nh gi\u00e1 b\u1eaft bu\u1ed9c ph\u1ea3i th\u1ef1c hi\u1ec7n, c\u00f3 t\u00ednh \u0111\u1ebfn d\u1eef li\u1ec7u C\u1ea3nh gi\u00e1c d\u01b0\u1ee3c,bao g\u1ed3m d\u1eef li\u1ec7u \u0111\u01b0\u1ee3c xem x\u00e9t tr\u01b0\u1edbc \u0111\u00f3, b\u1ea5t c\u1ee9 d\u1eef li\u1ec7u n\u00e0o kh\u00e1c xu\u1ea5t hi\u1ec7n t\u1eeb n\u0103m 2014, c\u00e1c b\u00e1o c\u00e1o tr\u01b0\u1eddng h\u1ee3p ri\u00eang l\u1ebb v\u00e0 c\u00e1c t\u00e0i li\u1ec7u tham kh\u1ea3o.<\/p>\n<p>D\u1ef1a tr\u00ean c\u00e1c m\u1ed1i nguy c\u01a1 an to\u00e0n v\u00e0 c\u00e1c \u0111\u1ed9ng th\u00e1i c\u1ea7n thi\u1ebft ph\u1ea3i th\u1ef1c hi\u1ec7n tr\u00ean ph\u1ea1m vi to\u00e0n EU, \u1ee6y ban Ch\u00e2u \u00c2u xem x\u00e9t \u0111\u1ec1 c\u1eadp v\u1ea5n \u0111\u1ec1 tr\u00ean v\u1edbi PRAC v\u00e0 y\u00eau c\u1ea7u h\u1ecd \u0111\u01b0a ra khuy\u1ebfn ngh\u1ecb theo \u0110i\u1ec1u 31, Ch\u1ec9 th\u1ecb 2001\/83\/EC v\u1ec1 vi\u1ec7c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh c\u00e1c s\u1ea3n ph\u1ea9m tr\u00ean n\u00ean \u0111\u01b0\u1ee3c suy tr\u00ec, thay \u0111\u1ed5i, \u0111\u00ecnh ch\u1ec9 hay thu h\u1ed3i.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/estradiol-containing-001-w\/w-medicinal-products-topical-use-article-31-referral-notification_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/estradiol-containing-001-w\/w-medicinal-products-topical-use-article-31-referral-notification_en.pdf<\/a><\/p>\n<h2>Annex I<\/h2>\n<p>Th\u00f4ng tin chi ti\u1ebft v\u1ec1 danh s\u00e1ch s\u1ea3n ph\u1ea9m ch\u1ee9a estradiol (0.01% w\/w) s\u1eed d\u1ee5ng t\u1ea1i ch\u1ed7, d\u1ea1ng b\u00e0o ch\u1ebf, h\u00e0m l\u01b0\u1ee3ng, \u0111\u01b0\u1eddng d\u00f9ng, c\u00f4ng ty l\u01b0u h\u00e0nh \u1edf c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU<\/p>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>N\u01b0\u1edbc l\u01b0u h\u00e0nh<\/td>\n<td>C\u00f4ng ty l\u01b0u h\u00e0nh<\/td>\n<td>T\u00ean s\u1ea3n ph\u1ea9m<\/td>\n<td>Ho\u1ea1t ch\u1ea5t + H\u00e0m l\u01b0\u1ee3ng<\/td>\n<td>D\u1ea1ng b\u00e0o ch\u1ebf<\/td>\n<td>\u0110\u01b0\u1eddng d\u00f9ng<\/td>\n<\/tr>\n<tr>\n<td>Austria<\/td>\n<td>Pharmazeutische Fabrik Montavit Ges.M.B.H<\/td>\n<td>Montadio<\/td>\n<td>Estradiol Hemihydrate 0.1033mgg<\/td>\n<td>Kem b\u00f4i<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Austria<\/td>\n<td>Pharmazeutische Fabrik Montavit Ges.M.B.H<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033mgg<\/td>\n<td>S\u1eefa b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Bulgaria<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>\u041b\u0438\u043d\u043e\u043b\u0430\u0434\u0438\u043e\u043b N<\/td>\n<td>Estradiol Hemihydrate 0.1033g\/100g<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Croatia<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033mgg<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Czech Republic<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033g\/100g<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Estonia<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033g\/100g<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Germany<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Estradiol-Hemihydrat Wolff<\/td>\n<td>Estradiol Hemihydrate 0.1033g\/100g<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Germany<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033g\/100g<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Hungary<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033g\/100g<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Latvia<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033mgg<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Lithuania<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033mgg<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<tr>\n<td>Slovakia<\/td>\n<td>Dr. August Wolff Gmbh &amp; Co. Kg Arzneimittel<\/td>\n<td>Linoladiol<\/td>\n<td>Estradiol Hemihydrate 0.1033mgg<\/td>\n<td>Kem b\u00f4i \u00e2m \u0111\u1ea1o<\/td>\n<td>\u00c2m \u0111\u1ea1o<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Ngu\u1ed3n:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/estradiol-containing-001-w\/w-medicinal-products-topical-use-article-31-referral-annex-i_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/estradiol-containing-001-w\/w-medicinal-products-topical-use-article-31-referral-annex-i_en.pdf<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u0110\u00e1nh gi\u00e1 m\u1edbi c\u1ee7a EMA v\u1ec1 nguy c\u01a1 c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m kem b\u00f4i ch\u1ee9a estradiol h\u00e0m l\u01b0\u1ee3ng cao EMA \u0111\u00e3 b\u1eaft \u0111\u1ea7u m\u1ed9t \u0111\u00e1nh gi\u00e1 m\u1edbi v\u1ec1 c\u00e1c lo\u1ea1i kem c\u00f3 ch\u1ee9a estradiol h\u00e0m l\u01b0\u1ee3ng cao (0.01% w \/ w) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u01b0\u1eddng \u00e2m \u0111\u1ea1o \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb \u1edf ph\u1ee5 n\u1eef b\u1ecb teo [&#8230;]\n","protected":false},"author":1,"featured_media":8819,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-8817","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\/8817","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=8817"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/8817\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/8819"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=8817"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=8817"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=8817"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}