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 㰡 (Centralized Procedure) 30 Ǹ㰡 Ȯ Ӹ ƴ϶, 㰡 Ͽٴ ø ǰ Ʈ 忡 ˷ȴٴ ǹ̰ ũ.
Ʈ ̹ EMA 㰡 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 ߿ 7Ⱓ 2,000 Ͽ,ֱ Ƽ ȸ ɰ ȣ EMA 㰡 յΰ ü̿ùзμ 븦 ƿԴ.