#

Dailypharm Live Search Close
  • Alvogen voluntarily recalls Comtan Tab due to impurities
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | Sep 3, 2024 05:53am
Excess impurities detected in NDEA during post-marketing stability testing

Single-agent entacapones, which are used for Parkinson's syndrome, are being recalled due to the detection of excess impurities.

The issue of drug impurities continues to arise after MFDS has added nitrosamine impurity testing as a quality control test item to strengthen the management of nitrosamine impurities.

On March 30, MFDS announced the recall of Alvogen Korea's Comtan Tab 200mg (entacapone) due to the detection of excess NDEA in the post-market stability test.

In April, following the company's report that N-nitrosodiethylamine (NDEA) impurities were detected in its single agent entacapone, the MFDS began reviewing safety measures, including setting necessary temporary permissible standards based on
  • 0
Reader Comment
0
Anonymity comment Write Operate Rule
Colse

´ñ±Û ¿î¿µ¹æ½ÄÀº

´ñ±ÛÀº ½Ç¸í°ÔÀç¿Í À͸í°ÔÀç ¹æ½ÄÀÌ ÀÖÀ¸¸ç, ½Ç¸íÀº À̸§°ú ¾ÆÀ̵𰡠³ëÃâµË´Ï´Ù. À͸íÀº ÇʸíÀ¸·Î µî·Ï °¡´ÉÇϸç, ´ë´ñ±ÛÀº À͸íÀ¸·Î µî·Ï °¡´ÉÇÕ´Ï´Ù.

´ñ±Û ³ëÃâ¹æ½ÄÀº

´ñ±Û ¸í¿¹ÀÚ¹®À§¿ø(ÆÊ-ÄڴϾð-Çʱâ¸ð¾ç ¾ÆÀÌÄÜ)À¸·Î À§ÃËµÈ µ¥Àϸ®ÆÊ È¸¿øÀÇ ´ñ±ÛÀº ¡®°Ô½ÃÆÇÇü º¸±â¡¯¿Í ¡¯ÆîÃ帱âÇü¡¯ ¸®½ºÆ®¿¡¼­ Ç×»ó ÃÖ»ó´Ü¿¡ ³ëÃâµË´Ï´Ù. »õ·Î¿î ´ñ±ÛÀ» ¿Ã¸®´Â ÀϹÝȸ¿øÀº ¡®°Ô½ÃÆÇÇü¡¯°ú ¡®ÆîÃ帱âÇü¡¯ ¸ðµÎ ÆÊÄڴϾð ȸ¿øÀÌ ¾´ ´ñ±ÛÀÇ ÇÏ´Ü¿¡ ½Ç½Ã°£ ³ëÃâµË´Ï´Ù.

´ñ±ÛÀÇ »èÁ¦ ±âÁØÀº

´ÙÀ½ÀÇ °æ¿ì »çÀü Å뺸¾øÀÌ »èÁ¦ÇÏ°í ¾ÆÀ̵ð ÀÌ¿ëÁ¤Áö ¶Ç´Â ¿µ±¸ °¡ÀÔÁ¦ÇÑÀÌ µÉ ¼öµµ ÀÖ½À´Ï´Ù.

  • ÀúÀ۱ǡ¤ÀÎ°Ý±Ç µî ŸÀÎÀÇ ±Ç¸®¸¦ ħÇØÇÏ´Â °æ¿ì

    »ó¿ë ÇÁ·Î±×·¥ÀÇ µî·Ï°ú °ÔÀç, ¹èÆ÷¸¦ ¾È³»ÇÏ´Â °Ô½Ã¹°

    ŸÀÎ ¶Ç´Â Á¦3ÀÚÀÇ ÀúÀÛ±Ç ¹× ±âŸ ±Ç¸®¸¦ ħÇØÇÑ ³»¿ëÀ» ´ãÀº °Ô½Ã¹°

  • ±Ù°Å ¾ø´Â ºñ¹æ¡¤¸í¿¹¸¦ ÈѼÕÇÏ´Â °Ô½Ã¹°

    ƯÁ¤ ÀÌ¿ëÀÚ ¹× °³Àο¡ ´ëÇÑ ÀνŠ°ø°ÝÀûÀÎ ³»¿ëÀÇ ±Û ¹× Á÷Á¢ÀûÀÎ ¿å¼³ÀÌ »ç¿ëµÈ °æ¿ì

    ƯÁ¤ Áö¿ª ¹× Á¾±³°£ÀÇ °¨Á¤´ë¸³À» Á¶ÀåÇÏ´Â ³»¿ë

    »ç½Ç È®ÀÎÀÌ ¾ÈµÈ ¼Ò¹®À» À¯Æ÷ ½ÃÅ°´Â °æ¿ì

    ¿å¼³°ú ºñ¾î, ¼Ó¾î¸¦ ´ãÀº ³»¿ë

    Á¤´ç¹ý ¹× °øÁ÷¼±°Å¹ý, °ü°è ¹ý·É¿¡ ÀúÃ˵Ǵ °æ¿ì(¼±°üÀ§ ¿äû ½Ã Áï½Ã »èÁ¦)

    ƯÁ¤ Áö¿ªÀ̳ª ´Üü¸¦ ºñÇÏÇÏ´Â °æ¿ì

    ƯÁ¤ÀÎÀÇ ¸í¿¹¸¦ ÈѼÕÇÏ¿© ÇØ´çÀÎÀÌ »èÁ¦¸¦ ¿äûÇÏ´Â °æ¿ì

    ƯÁ¤ÀÎÀÇ °³ÀÎÁ¤º¸(Áֹεî·Ï¹øÈ£, ÀüÈ­, »ó¼¼ÁÖ¼Ò µî)¸¦ ¹«´ÜÀ¸·Î °Ô½ÃÇÏ´Â °æ¿ì

    ŸÀÎÀÇ ID ȤÀº ´Ð³×ÀÓÀ» µµ¿ëÇÏ´Â °æ¿ì

  • °Ô½ÃÆÇ Æ¯¼º»ó Á¦ÇѵǴ ³»¿ë

    ¼­ºñ½º ÁÖÁ¦¿Í ¸ÂÁö ¾Ê´Â ³»¿ëÀÇ ±ÛÀ» °ÔÀçÇÑ °æ¿ì

    µ¿ÀÏ ³»¿ëÀÇ ¿¬¼Ó °ÔÀç ¹× ¿©·¯ ±â»ç¿¡ Áߺ¹ °ÔÀçÇÑ °æ¿ì

    ºÎºÐÀûÀ¸·Î º¯°æÇÏ¿© ¹Ýº¹ °ÔÀçÇÏ´Â °æ¿ìµµ Æ÷ÇÔ

    Á¦¸ñ°ú °ü·Ã ¾ø´Â ³»¿ëÀÇ °Ô½Ã¹°, Á¦¸ñ°ú º»¹®ÀÌ ¹«°üÇÑ °æ¿ì

    µ·¹ú±â ¹× Á÷¡¤°£Á¢ »ó¾÷Àû ¸ñÀûÀÇ ³»¿ëÀÌ Æ÷ÇÔµÈ °Ô½Ã¹°

    °Ô½Ã¹° Àбâ À¯µµ µîÀ» À§ÇØ ³»¿ë°ú ¹«°üÇÑ Á¦¸ñÀ» »ç¿ëÇÑ °æ¿ì

  • ¼ö»ç±â°ü µîÀÇ °ø½ÄÀûÀÎ ¿äûÀÌ ÀÖ´Â °æ¿ì

  • ±âŸ»çÇ×

    °¢ ¼­ºñ½ºÀÇ Çʿ伺¿¡ µû¶ó ¹Ì¸® °øÁöÇÑ °æ¿ì

    ±âŸ ¹ý·ü¿¡ ÀúÃ˵Ǵ Á¤º¸ °ÔÀ縦 ¸ñÀûÀ¸·Î ÇÒ °æ¿ì

    ±âŸ ¿ø¸¸ÇÑ ¿î¿µÀ» À§ÇØ ¿î¿µÀÚ°¡ ÇÊ¿äÇÏ´Ù°í ÆǴܵǴ ³»¿ë

  • »ç½Ç °ü°è È®ÀÎ ÈÄ »èÁ¦

    ÀúÀÛ±ÇÀڷκÎÅÍ Çã¶ô¹ÞÁö ¾ÊÀº ³»¿ëÀ» ¹«´Ü °ÔÀç, º¹Á¦, ¹èÆ÷ÇÏ´Â °æ¿ì

    ŸÀÎÀÇ ÃÊ»ó±ÇÀ» ħÇØÇϰųª °³ÀÎÁ¤º¸¸¦ À¯ÃâÇÏ´Â °æ¿ì

    ´ç»ç¿¡ Á¦°øÇÑ ÀÌ¿ëÀÚÀÇ Á¤º¸°¡ ÇãÀ§ÀÎ °æ¿ì (ŸÀÎÀÇ ID, ºñ¹Ð¹øÈ£ µµ¿ë µî)

  • ¡ØÀÌ»óÀÇ ³»¿ëÁß ÀϺΠ»çÇ׿¡ Àû¿ëµÉ °æ¿ì ÀÌ¿ë¾à°ü ¹× °ü·Ã ¹ý·ü¿¡ ÀÇÇØ Á¦À縦 ¹ÞÀ¸½Ç ¼öµµ ÀÖÀ¸¸ç, ¹Î¡¤Çü»ç»ó ó¹úÀ» ¹ÞÀ» ¼öµµ ÀÖ½À´Ï´Ù.

    ¡ØÀ§¿¡ ¸í½ÃµÇÁö ¾ÊÀº ³»¿ëÀÌ´õ¶óµµ ºÒ¹ýÀûÀÎ ³»¿ëÀ¸·Î ÆǴܵǰųª µ¥Àϸ®ÆÊ ¼­ºñ½º¿¡ ¹Ù¶÷Á÷ÇÏÁö ¾Ê´Ù°í ÆǴܵǴ °æ¿ì´Â ¼± Á¶Ä¡ ÀÌÈÄ º» °ü¸® ±âÁØÀ» ¼öÁ¤ °ø½ÃÇÏ°Ú½À´Ï´Ù.

    ¡Ø±âŸ ¹®ÀÇ »çÇ×Àº µ¥Àϸ®ÆÊ ¿î¿µÀÚ¿¡°Ô ¿¬¶ôÁֽʽÿÀ. ¸ÞÀÏ ÁÖ¼Ò´Â dailypharm@dailypharm.comÀÔ´Ï´Ù.

Write
Write
recently Agree DisAgree
If you want to see the full article, please JOIN US (click)