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FDA, Ʈ Ʈø 򰡡 ɼ  
̼ 2018-10-10 12:20:16
FDA, Ʈ Ʈø 򰡡 ɼ  
̼ 2018-10-10 12:20:16
׾ ڹȸ, ſ 򰡡ǥ յΰ



Ʈ ̿ùз 'Ʈø( )' ̱ ɼ .

̱ ǰǾ౹(FDA) ׾ ڹȸ(ODAC, Oncologic Drugs Advisory Committee) 10(̱ ð) ǰ ǥ(vote) յΰ Ʈø ν ſ (highly similar)ϴٰ гȴ.

  FDA ODAC Briefing Documnet Ϻ .

ֱ ODAC Briefing Document , ڹ Ʈø(CT-P10) ̳ϰ ٸ , ſ ϴ(The totality of analytical support the determination that CT-P10 is highly similar to US-licensed Rituxan, notwithstanding minor differences in clinically inactive components.) ߴ.

ӻ ǹ̾(There are no clinically meaningful differences between CT-P10 and US-licensed Rituxan in terms of safety, purity and potency of the product) Ǵߴ.

Ʈø ǰ ǥ 10(̱ ð) ȴ. 㰡 ǰ 11 4ֳ 12 1 ȴ. Ʈø ν ̱ ̿ùз ȴ.

FDA ڹ ù ̿ùз ν ֵȴ. Ʈ ̵ ̿ùз ÷Ʈ(̱ ø ǰ) 2016 2 10 ڹ αǰ ǰ ȹߴ. ƾ ù ̿ùз ϶(Mylan) 긮(Ogivri) Ҵ.

Ʈ 17 FDA ǻ cGMP ̻ Ȯ ǻ (EIR) ߴ.

(Warning Letter) ̽ ؼҵ ̴. FDA 2017 5 ǻ ߰ 䱸 Form 483 ͸ ϰ 7 ǻ縦 ƴ Ȯߴ.

FDA ǻ Ʈ cGMP ߰, ü ̶ VAI(Voluntary Action Indicated) ߴ.
̼ (wiviwivi@dailypharm.com) ٸ
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 04)
౹ 31
ǰ ְ
ѽŻ÷(10) 3,500 2,500 1,000 3,009
޾(100) 24,000 23,000 1,000 23,200
Ʒγΰ(100) 30,000 28,000 2,000 28,500
īɾ(10g) 7,000 6,000 1,000 6,559
Ľõ򿬰(5g) 5,000 4,500 500 5,138
Ź(4) 5,000 4,000 1,000 4,438
ڶ(20) 6,000 6,000 0 6,000
(10) 6,000 4,500 1,500 5,071
Ժ(10) 4,000 3,500 500 3,712
ڱ׸(20) 5,000 4,500 500 4,717
ť(10) 3,000 2,500 500 2,990
Ȱť(1) 1,200 900 300 1,182
Ǯɾ(3.3ml) 26,000 23,000 3,000 24,250
޵𿬰(10g) 7,000 5,900 1,100 6,289
öŸ(34) 13,000 11,000 2,000 11,866
뽺ī(20g) 22,000 18,000 4,000 20,184
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,500 1,500 9,205
ͺ(10) 3,500 3,000 500 3,196
ݿ(1ڽ) 3,000 3,000 0 3,000
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,524
߽Ÿ(120) 70,000 50,000 20,000 60,385
Źĸ(10ĸ) 3,000 2,000 1,000 2,989
Ÿ̾(120) 60,000 50,000 10,000 51,538
տ(60ĸ) 29,000 25,000 4,000 27,600
Ÿ̷ER(6) 3,000 2,500 500 2,750
ٿ(30g) 12,000 9,000 3,000 11,444
(120) 25,000 22,000 3,000 24,991
Ʒ(6) 4,000 3,000 1,000 3,262
ǽõĸ(270ĸ) 110,000 110,000 0 110,000
B(120) 70,000 70,000 0 70,000
׳(10) 3,000 2,500 500 2,778
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 220,000 10,000 223,333
Ⱦ 12,000 10,000 2,000 10,143
̰źĸ(60ĸ) 35,000 30,000 5,000 33,231
Ųť(20) 5,500 4,500 1,000 4,903
λ絹÷(100) 35,000 32,000 3,000 33,297
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ͳݽŹϹȣ: 00048 | 2005.09.09 | 2005.09.09 | : | : ȣ
ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
ȭ : 02-3473-0833 |ѽ : 02-3474-0169 | ûҳ⺸ȣå(å ű)
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