์ฝ”์˜ค๋กฑ์ƒ๋ช…๊ณผํ•™๋กœ์ˆ˜๋ฐ”์Šคํƒ€ํ‹ด์นผ์Š˜(์›๋ฃŒ)(์ˆ˜์ถœ์šฉ)(์ˆ˜์ถœ๋ช…:Rosuvastatin Calcium)

๊ตญ๊ฐ€: ๋Œ€ํ•œ๋ฏผ๊ตญ

์–ธ์–ด: ํ•œ๊ตญ์–ด

์ถœ์ฒ˜: MFDS (์‹ํ’ˆ ์˜์•ฝํ’ˆ ์•ˆ์ „๋ถ€)

์ง€๊ธˆ ๊ตฌ๋งคํ•˜์„ธ์š”

์œ ํšจ ์„ฑ๋ถ„:

4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsufonyl)Amino]Pyrimidine-5-Yl-Methanol/(4-Fluorophenyl)-6-Isopropyl-2-(N-Methylmethylsulfonamido)Pyrimidin-5-Yl)Methyl)Triphenylphosphonium Chloride/Cyclopentyl 2-[(4R,6S)-6-Formyl-2,2-Dimethyl-1,3-Dioxan-4-Yl]Acetate/N-[4-(4-Fluorophenyl)-5-(hydroxymethyl)-6-(1-methylethyl)-2-pyrimidinyl]-N-methylmethanesulfonamide/tert-Butyl(4R-cis)-6-formaldehydel-2,2-dimethyl-1,3-dioxane-4-acetate

์ œ๊ณต์ฒ˜:

KOLON LIFE SCIENCE

ATC ์ฝ”๋“œ:

-

INN (International Name):

4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsufonyl)Amino]Pyrimidine-5-Yl-Methanol/(4-Fluorophenyl)-6-Isopropyl-2-(N-Methylmethylsulfonamido)Pyrimidin-5-Yl)Methyl)Triphenylphosphonium Chloride/Cyclopentyl 2-[(4R,6S)-6-Formyl-2,2-Dimethyl-1,3-Dioxan-4-Yl]Acetate/N-[4-(4-Fluorophenyl)-5-(hydroxymethyl)-6-(1-methylethyl)-2-pyrimidinyl]-N-methylmethanesulfonamide/tert-Butyl(4R-cis)-6-formaldehydel-2,2-dimethyl-1,3-dioxane-4-acetate

์•ฝ์ œ ํ˜•ํƒœ:

ํฐ์ƒ‰์˜ ๊ฐ€๋ฃจ

๊ตฌ์„ฑ:

์ฒจ๊ฐ€์ œ : ์‹œํด๋กœํŽœํ‹ธ 2-((4R,6S)-6-ํฌ๋ฅด๋ฐ€-2,2'-๋””๋ฉ”ํ‹ธ-1,3-๋””์˜ฅ์‚ฐ-4-์ผ)์•„์„ธํ…Œ์ดํŠธ, ํ†จ๋ฃจ์—”์„คํฐ์‚ฐ, ํ™œ์„ฑํƒ„, ํŠธ๋ฆฌ์—ํ‹ธ์•„๋ฏผ, ๋ฉ”ํ‹ธ๋ Œํด๋กœ๋ผ์ด๋“œ, ํ…ŒํŠธ๋ผ๋ถ€ํ‹ธ๋ฉ”ํ‹ธ์—ํ…Œ๋ฅด, ์ˆ˜์‚ฐํ™”๋‚˜ํŠธ๋ฅจ, ํ™ฉ์‚ฐ๋‚˜ํŠธ๋ฅจ, (4-ํ”Œ๋ฃจ์˜ค๋กœํŽ˜๋‹)-6-์ด์†Œํ”„๋กœํ•„-2-(N-๋ฉ”ํ‹ธ๋ฉ”ํ‹ธ์„คํฐ์•„๋ฏธ๋„)ํ”ผ๋ฆฌ๋ฏธ๋”˜-5-์ผ)๋ฉ”ํ‹ธ)ํŠธ๋ฆฌํŽ˜๋‹ํฌ์Šคํฌ๋Š„ํด๋กœ๋ผ์ด๋“œ, ํ†จ๋ฃจ์—”, ์—ผํ™”์นผ์Š˜์ด์ˆ˜ํ™”๋ฌผ, ์—ผํ™”๋‚˜ํŠธ๋ฅจ, ๋ฉ”ํƒ„์„คํฌ๋‹ํด๋กœ๋ผ์ด๋“œ, ์—ผ์‚ฐ, ๋ฉ”ํƒ„์˜ฌ, ํ…ŒํŠธ๋ผํžˆ๋“œ๋กœํ‘ธ๋ž€, ๋””๋ฉ”ํ‹ธ์„คํญ์‹œ๋“œ, ํƒ„์‚ฐ์นผ๋ฅจ, ํŠธ๋ฆฌํŽ˜๋‹ํฌ์Šคํ•€, ์—ํ‹ธ์•„์„ธํ…Œ์ดํŠธ, ์•„์„ธํŠธ์‚ฐ๋‚˜ํŠธ๋ฅจ, ์ •์ œ์ˆ˜, 4-(4-ํ”Œ๋ฃจ์˜ค๋กœํŽ˜๋‹)-6-์ด์†Œํ”„๋กœํ•„-2-[(N-๋ฉ”ํ‹ธ-N-๋ฉ”ํ‹ธ์„คํฌ๋‹)์•„๋ฏธ๋…ธ]ํ”ผ๋ฆฌ๋ฏธ๋”˜-5-์ผ-๋ฉ”ํƒ„์˜ฌ

์ฒ˜๋ฐฉ์ „ ์œ ํ˜•:

์›๋ฃŒ์˜์•ฝํ’ˆ

์น˜๋ฃŒ ์ง•ํ›„:

์˜์•ฝํ’ˆ ์กฐ์ œ ๋˜๋Š” ์กฐ์ œ์šฉ

์ œํ’ˆ ์š”์•ฝ:

์šฉ๋ฒ•์šฉ๋Ÿ‰ : ์˜์•ฝํ’ˆ ์กฐ์ œ ๋˜๋Š” ์ œ์กฐ์šฉ ์‚ฌ์šฉ์ƒ์˜์ฃผ์˜์‚ฌํ•ญ : 1. ์˜์•ฝํ’ˆ ์กฐ์ œ ๋˜๋Š” ์ œ์กฐ์šฉ์œผ๋กœ๋งŒ ์‚ฌ์šฉํ•œ๋‹ค. 2. ๋‹จ์ผ์ œ์˜ ์‚ฌ์šฉ์˜ˆ๊ฐ€ ์žˆ๋Š” ๊ฒฝ์šฐ ๋‹จ์ผ์ œ "์‚ฌ์šฉ์ƒ์˜ ์ฃผ์˜์‚ฌํ•ญ"์„ ์ฐธ์กฐํ•œ๋‹ค. 3. ๋ณด๊ด€ ๋ฐ ์ทจ๊ธ‰์ƒ์˜ ์ฃผ์˜์‚ฌํ•ญ 1) ์˜จ๋„, ํ–‡๋ณ•, ์Šต๋„ ๋“ฑ์— ๊ด€ํ•˜์—ฌ ์ฃผ์˜ํ•˜์—ฌ ๋ณด๊ด€ํ•œ๋‹ค. 2) ์›๋ž˜ ์šฉ๊ธฐ์—์„œ ๊บผ๋‚ด์–ด ๋‹ค๋ฅธ ์šฉ๊ธฐ์— ๋ณด๊ด€ํ•˜๋Š” ๊ฒƒ์€ ์˜ค์šฉ์— ์˜ํ•œ ์‚ฌ๊ณ  ๋ฐœ์ƒ์ด๋‚˜ ์˜์•ฝํ’ˆ ํ’ˆ์งˆ์ €ํ•˜์˜ ์›์ธ์ด ๋  ์ˆ˜ ์žˆ์œผ๋ฏ€๋กœ ์›๋ž˜ ์šฉ๊ธฐ์— ๋„ฃ๊ณ  ๊ผญ ๋‹ซ์•„ ๋ณด๊ด€ํ•œ๋‹ค.

์Šน์ธ ๋‚ ์งœ:

2014-05-22

์ œํ’ˆ ํŠน์„ฑ ์š”์•ฝ

                                ํšจ๋Šฅํšจ๊ณผ
์˜์•ฝํ’ˆ์กฐ์ œ๋˜๋Š”์กฐ์ œ์šฉ
์šฉ๋ฒ•์šฉ๋Ÿ‰
์˜์•ฝํ’ˆ์กฐ์ œ๋˜๋Š”์ œ์กฐ์šฉ
์‚ฌ์šฉ์ƒ์˜์ฃผ์˜์‚ฌํ•ญ
1.์˜์•ฝํ’ˆ์กฐ์ œ๋˜๋Š”์ œ์กฐ์šฉ์œผ๋กœ๋งŒ์‚ฌ์šฉํ•œ๋‹ค.
2.๋‹จ์ผ์ œ์˜์‚ฌ์šฉ์˜ˆ๊ฐ€์žˆ๋Š”๊ฒฝ์šฐ๋‹จ์ผ์ œ"์‚ฌ์šฉ์ƒ์˜์ฃผ์˜์‚ฌํ•ญ"์„์ฐธ์กฐํ•œ๋‹ค.
3.๋ณด๊ด€๋ฐ์ทจ๊ธ‰์ƒ์˜์ฃผ์˜์‚ฌํ•ญ
1)์˜จ๋„,ํ–‡๋ณ•,์Šต๋„๋“ฑ์—๊ด€ํ•˜์—ฌ์ฃผ์˜ํ•˜์—ฌ๋ณด๊ด€ํ•œ๋‹ค.
2)์›๋ž˜์šฉ๊ธฐ์—์„œ๊บผ๋‚ด์–ด๋‹ค๋ฅธ์šฉ๊ธฐ์—๋ณด๊ด€ํ•˜๋Š”๊ฒƒ์€์˜ค์šฉ์—์˜ํ•œ์‚ฌ๊ณ ๋ฐœ์ƒ์ด๋‚˜์˜์•ฝํ’ˆํ’ˆ์งˆ์ €ํ•˜์˜์›์ธ์ด
๋ ์ˆ˜์žˆ์œผ๋ฏ€๋กœ์›๋ž˜์šฉ๊ธฐ์—๋„ฃ๊ณ ๊ผญ๋‹ซ์•„๋ณด๊ด€ํ•œ๋‹ค.
                                
                                ์ „์ฒด ๋ฌธ์„œ ์ฝ๊ธฐ