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Ʈ ø, üġ ̿ùз EMA
  • ۼ 2013-07-01 13:40:00
  • ȸ 6401

 

Ʈ ø, EMA 㰡ǰ ȹ

 

- EU 27, EEA 3 30 㰡 ü ̿ùз

- ǰ ܻ ǰ Ȯ, Ȯ

- üǾǰ ȭô ,ѱ ۷ι ÷̾ ȣź

 

Ʈ 28 ü ڰ鿪ȯġ ø(Remsima) Ǹſ EMA(Ǿǰû)κ 㰡ǰ ޾Ҵٰ .̷μ EU 27 EEA() 3 30 㰡 ø Ǹ㰡 ְ ƴ.

 

ø Ǹ㰡 ü ̿ùз̸,ǸŸ ƴ EMA Ǿǰ 㰡 Ǿǰ Ǿ.

ø ô߿, Ƽ ۷ι ӻ 1 3 ȿ 鿡 Ͽ,̸ EMAκ Ƽ , ô߿, ũк, ˾缺 忰,Ǽ, Ǽ , Ҿũк ܻ(extrapolation) ޾Ҵ.

 

ø ۷ιӻ åӿ(PI) Ѿб ø ߴܰ ӻ迡 Ǿǰ  Ͽ , EMAκ ޾ ǰ ϰ ȯڿ óϴµ ȴ١ ȿ Ǿǰ ȯڵ鿡 ġȸ ־ Ƿ迡 Ʈ ⿡ ִ١ ߴ.

 

̹ ø EMA ǰ 㰡 ۿ ȿ پ üǾǰ ȭ ô븦 ٴ ȹ ǥ δ.üǾǰ ׵ ȯڵ ϴ Ѱ踦 ־, üǾǰ ̿ùз ڷ ū 3 ⼺ Ͽ ׵ Ұ νĵſԴ.Ư ѱ 簡 ۷ι ȭ ȭ ̴ ü ̿ùз ,ϰ ִٴ ۷ι ȣź ȴ.

 

Ǿǰû(EMA) ʷ ̿ùз 㰡 ̵ , EMA Ǿǰ 㰡 ø ۷ι ø ȭϴ ȴ.Ư, EMA (Centralized Procedure) 30 Ǹ㰡 Ȯ Ӹ ƴ϶, 㰡 Ͽٴ ø ǰ Ʈ 忡 ˷ȴٴ ǹ̰ ũ.

Ʈ ̹ EMA 30(267 ޷) ϴ TNF- üġ ִ ϰ ƴ. 3 Ϲ ǰ ü ϰ ,ø 10% Ѵٰ 3 ϴٴ ´.̴ ѱ ǰ ִ Ǿǰ ź ϴ , 1 ġ ϰ ִ ǿ ̷ ִ Ŀ ź ǹѴٰ ִ.

 

Ʈ ȸ ø ȿ ϸ鼭 ϱ Ƿ δ㿡 ģ Ƿ ȯڵ鿡 ,׵ üǾǰ ߵ ȯڵ鿡Ե ټ δ١ ߴ. ȸ TNF- üġ ̿ùз ӻ ȸ簡 Ʈ Ŵ 忡 ּ 4~5⵿ ̿ùзμ Ȯ ̶͡ ߴ.

 

Ʈ 2006 ۷ι ӻ ϰ ǰ㰡 ޱ ø ߿ 7 2,000 Ͽ,ֱ Ƽ ȸ ɰ ȣ ޴ EMA 㰡 յΰ ü̿ùзμ 븦 ޾ƿԴ.

 






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