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  ű ǰ, ǰ ǰ : DLUCPT75J  ۼ

					

					

 

 

HL 23-50

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ű ǰ, ǰ ǰ ˷帮 ῡ Ͻñ ٶϴ.

 

 

339. Ÿ ü׿

Luspatercept

DLUCPT75J 75mg/Vial Reblozyl Inj 75mg( 75mg)(BMS) (339)(޿)

DLUCPT25J 25mg/Vial Reblozyl Inj 25mg( 25mg)(BMS) (339)(޿)

[] ܹ μ -Ÿ(TGF-) superfamily 忡 Ͽ Smad2/3 ȣ ҽŴν, ü ȭ Ű ȿ õ ǥ .

[ȿ] 1. ڱ(ESA) ġῡ ų Ͽ ʿ ȯ ġ.

- , , ߵ ö ̻ı(MDS-RS).

- , , ߵ ö𱸿 ̻/.

2. ʿ Ÿ ȯ ġ.

[] 1. ̻ı.

ȸ 1.0mg/kg, 3ָ 1ȸ SC.

1.0mg/kg 뷮 ּ 2ȸ Ŀ ʿ, 1.33mg/kg .

1.33mg/kg 뷮 ּ 2ȸ Ŀ ʿ 1.75mg/kg.

ּ 6(2ȸ Ⱓ)̻, ִ 뷮 3ָ 1.75mg/kg.

2. Ÿغ

ȸ 1.0mg/kg, 3ָ 1ȸ SC.

1.0mg/kg 2ȸ ̻ (6) δ 1/3 Ҹ ޼ , 1.25mg/kg . ִ 뷮 3ָ 1.25mg/kg.

[] , , , , , , , ǽ/ǽ, , ΰ, , , , , ÷翣, , μ , , ôй, , ü , , ȣ, ֻ, .

[ݱ] ּ Ǵ μ, ӽ.

[] ް Ÿ , շ , ӵǰų ȭ. ̿ ġ ȯ ġῡ ǻ簡 . ֻ 籸(25mg Vial ֻ 0.68mL, 75mg Vial ֻ 1.6mL 1 ġ), 籸 ϰų ణ ü. ٴ ȯڿ , 1.2mL ʰ , 뷮 ֻ . , Ҿ. 籸 ǿ(25 ) 8ð, (2~8C) 24ð. (2~8C) .

[Ӻ] Ȯ( ġϴ , ׸  3 ȿ ӹ ).

[] Ǿǰ.

 

 

 

 

 

 

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DFA263J

Human blood coagulation factor VIII (monoclonal) 263IU/Vial

Greenmono Inj 250IU

׸ 250

()

DFA259J ü

 

2023.09.07.

 

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ڵ

Է

ǰ

(ȸ)

ǽ

DPLN0.25F

Palonosetron 0.25mg/5mL PFS

Paloset Prefilled Inj 5mL

ȷμ ʵ 5mL

(ѹ)

2023.09.07.

 

ǰ

ڵ

Է

ǰ

(ȸ)

ǽ

DFA259J

Human blood coagulation factor VIII (monoclonal) 259IU/Vial

Greenmono Inj 250IU

׸ 250

()

Ͻǰ

ü:

DFA263J

DTPLSR100

Theophylline 100mg/Cap

Theolan-B SR Cap 100mg

׿ö ĸ 100mg

(˺)

Ͻǰ

ü:

׽ø

DDOXF400

DABPL100

 

 

DTPLSR200

Theophylline 200mg/Cap

Theolan-B SR Cap 200mg

׿ö ĸ 200mg

(˺)

DFLJ

Fluorescein sod. 500mg(10%)/5ml Vial

Fluorescite Inj 10%(Vial)

ķƮ ֻ 10%(Vial)

()

Ͻǰ

 

 

 

 

2023. 09. 07.

 

ǰ ( 9561)