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ȸ ҽ : ȸ '17 12 ߰ ڷ ȳ |
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ѱ̿Ǿǰȸ 2017 ̿IT÷
ȯ ̿Ǿǰ ؿ
ϱ 15
۷ι ڷ Ͽϴ.
(̱//Ϻ/߱/ε//߽/Ű/±/ȣ/þ/ƶ/Ʈ/εþ/Űź)
,
㰡 ü(ӻ, ǰ㰡, GMP),
ϵǾ ֽϴ.
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ѱ̿Ǿǰȸ
̿Ǿǰ ڷḦ ϰ
̿Ǿǰ ' Ͽϴ.
̿Ǿǰ Ȳ ϵǾ ֽϴ.
: Ȩ>ڷ>ȸ pdf
Ȩ α (ȸ : ȸ ̻)
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18 1 Ȩ ε
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Ȯϱ[Click] |
å Ͻô ȸ ̸(hyelim@kobia.kr) Ͻñ ٶϴ. ( )
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ǰǾǰó ҽ |
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Ϻ
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ǸŰ Ģ Ϻΰ('17.12.29.) |
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ֿ䳻
Ǵ ü óڿ ŹϿ ش ٸ ҿ Ұϰų ֵ ϰ, Ǹϴ δ ̱ Ͽ Ǹڰ ٸ Ǿǰ Ͽ ϴ 쿡 õ ƴ õ ֵ ϴ Ÿ Ϻ ̺ ϰ
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ο
ȳ |
Ǿǰ 濡 ̵Ρ ߰ |
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ǰǾǰó ̿ɻο ڿ ǰ, , ȿ ġ ϴ ߰ Ͽ 㰡ɻ Ȯϰ ̵ ߰
: ǰ㰡 Ǿǰ, Ǿǰ, , ȹ
ֿ䳻
-
- (, Ưм, м, ر, , ӻ, ӻ )
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Ǿǰ ǥ Ϻΰ() |
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Ǿǰ 뿡 ұϰ ۿ ؿ ϴ Ǿǰ ۿ ر Ȱȭ ֵ Ǿǰ ⳪ Ǵ ÷ι ϴ ϰ
ֿ䳻 : Ǿǰ ۿ ر ȳ ( 9 7)
1) Ǿǰ ⡤ Ǵ ÷ι Ǿǰ ۿ ѱǾǰ ر û ִٴ ȳ ż
2) Ǿǰ ۿ ر Ǿǰ Һڿ ˸ ִ ȫ ʿ Ȱȭ
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Ǻ ҽ |
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Ϻ
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ǽ ء Ϻΰ('17.12.28.) |
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Ȯ κδ ż ص
ֿ䳻
- κδ , Ϻ ( 3 1 3ȣ 4 5 ż)
- κδ Ϻ κδ ż (ǥ 1)
- ġ κδ, ֱ ݿ, ż ݿ (ǥ 2)
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̿Ǿǰ ӻ |
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û |
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ǰ |
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ܰ |
Ŭ
ġ
ڸ() |
20171229 |
Ǵ CTCL ڿ , ڿ ߷縿 /Ǵ 缱 Ͽ TLR 7/8 ۿ MEDI9197 1 , ü ӻ |
1 |
MEDI4736
(߷縿)
/MEDI9197 |
()彺 |
20171228 |
ȯڸ ? ȿ Ȯϱ
, ߴ, , ٱ, 2 ӻ |
2 |
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()ɹ |
20171226 |
EBV缺 NK/T ȯڸ VT-EBV-N ġ ȿ ϱ 2 ӻ |
2 |
VT-EBV-N |
Ʈ() |
20171219 |
̼Ƹ ġῡ ? ȿ ٱ, , ߴ, , , 2 ӻ |
2 |
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ֽȸ
ťƼ |
20171219 |
BCG ִ ǰ Ƿ ڸ ID93+GLA-SE ϰ 鿪 ȿ Žϱ , , , 2a ӻ |
2 |
3N001C |
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ؿ 㰡 Ȳ |
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̱ |
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Drug name |
Active Ingredients |
Submission
Classification |
Company |
Approval date |
ALTAFLUOR BENOX
NDA #208582 |
FLUORESCEIN SODIUM;BENOXIONATE HYDROCHLORIDE |
ź |
ALTAIRE PHARMS INC |
12/14/2017 |
GOPRELTO
NDA #209963 |
COCAINE HYDROCHLORIDE |
Ǵ |
GENUS LIFESCIENCES |
12/14/2017 |
PREXXARTAN
NDA #209139 |
VALSARTAN |
ſ뷮 |
CARMEL BIOSCIENCES INC |
12/19/2017 |
STEGLATRO
NDA #209803 |
ERTUGLIFLOZIN |
Ź |
MERCK SHARP DOHME |
12/19/2017 |
STEGLUJAN
NDA #209805 |
ERTUGLIFLOZIN;SITAGLIPTIN |
Ź
ź |
MERCK SHARP DOHME |
12/19/2017 |
SEGLUROMET
NDA #209806 |
ERTUGLIFLOZIN;METFORMIN HYDROCHLORIDE |
Ź
ź |
MERCK SHARP DOHME |
12/19/2017 |
MACRILEN
NDA #205598 |
MACIMORELIN |
Ź |
AETERNA ZENTARIS GMBH |
12/20/2017 |
BIVALIRUDIN;0.9% SODIUM CHLORIDE
NDA #208374 |
BIVALIRUDIN;0.9% SODIUM CHLORIDE |
Ǵ |
CELERITY PHARMACEUTICALS LLC |
12/21/2017 |
SIKLOS
NDA #208843 |
HYDROXYUREA |
ſ뷮 |
ADDMEDICA SAS |
12/21/2017 |
GIAPREZA
NDA #209360 |
ANGIOTENSIN II |
Ź |
LA JOLLA PHARMACEUTICAL CO |
12/21/2017 |
LUMIFY
NDA #208144 |
BRIMONIDINE TARTRATE |
Ǵ |
BAUSCH & LOMB |
12/22/2017 |
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ؿ ӻ Ȳ |
Notice |
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ؿ ӻȲ(̱ 55, 11, ߱5) ,
Ȯ Ȩ(ڷ>) εϿϴ.
ŷοð, Ȩ 湮Ͻþ ü ȮϽñ ٶϴ.
ؿ ӻȲ (2017.12.19.~2018.01.01.) Ȯ
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