Hemlibra (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 30 mg Vial Carton

NDC 50242-920 -01
Hemlibra ®
(emicizumab-kxwh)
Injection

30 mg/mL

For Subcutaneous Use.
Single-Dose Vial.
Discard Unused Portion.

ATTENTION: Dispense the enclosed
Medication Guide to each patient.

Rx only

1 vialGenentech

10195119

PRINCIPAL DISPLAY PANEL -- 30 mg Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg Vial Carton

NDC 50242-921 -01
Hemlibra ®
(emicizumab-kxwh)
Injection

60 mg/0.4 mL

For Subcutaneous Use.
Single-Dose Vial.
Discard Unused Portion.

ATTENTION: Dispense the enclosed
Medication Guide to each patient.

Rx only

1 vialGenentech

10195122

PRINCIPAL DISPLAY PANEL -- 60 mg Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 105 mg Vial Carton

NDC 50242-922 -01
Hemlibra ®
(emicizumab-kxwh)
Injection

105 mg/0.7 mL

For Subcutaneous Use.
Single-Dose Vial.
Discard Unused Portion.

ATTENTION: Dispense the enclosed
Medication Guide to each patient.

Rx only

1 vialGenentech

10195123

PRINCIPAL DISPLAY PANEL -- 105 mg Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Vial Carton

NDC 50242-923 -01
Hemlibra ®
(emicizumab-kxwh)
Injection

150 mg/mL

For Subcutaneous Use.
Single-Dose Vial.
Discard Unused Portion.

ATTENTION: Dispense the enclosed
Medication Guide to each patient.

Rx only

1 vialGenentech

10195121

PRINCIPAL DISPLAY PANEL -- 150 mg Vial Carton
(click image for full-size original)
HEMLIBRA emicizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-920
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emicizumab (emicizumab) emicizumab 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
Aspartic Acid
Arginine
POLOXAMER 188
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-920-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 1 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-920-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761083 11/16/2017
HEMLIBRA emicizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-921
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emicizumab (emicizumab) emicizumab 150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
Aspartic Acid
Arginine
POLOXAMER 188
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-921-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 0.4 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-921-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761083 11/16/2017
HEMLIBRA emicizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-922
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emicizumab (emicizumab) emicizumab 150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
Aspartic Acid
Arginine
POLOXAMER 188
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-922-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 0.7 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-922-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761083 11/16/2017
HEMLIBRA emicizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-923
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emicizumab (emicizumab) emicizumab 150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
Aspartic Acid
Arginine
POLOXAMER 188
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-923-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 1 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-923-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761083 11/16/2017
Labeler — Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
Chugai Pharma Manufacturing Co., Ltd. (Ukima) 691033815 API MANUFACTURE (50242-920), API MANUFACTURE (50242-921), API MANUFACTURE (50242-922), API MANUFACTURE (50242-923), ANALYSIS (50242-920), ANALYSIS (50242-921), ANALYSIS (50242-922), ANALYSIS (50242-923)
Establishment
Name Address ID/FEI Operations
Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya) 716464891 MANUFACTURE (50242-920), MANUFACTURE (50242-921), MANUFACTURE (50242-922), MANUFACTURE (50242-923), ANALYSIS (50242-920), ANALYSIS (50242-921), ANALYSIS (50242-922), ANALYSIS (50242-923)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd. (KAU) 485244961 ANALYSIS (50242-920), ANALYSIS (50242-921), ANALYSIS (50242-922), ANALYSIS (50242-923), LABEL (50242-920), LABEL (50242-921), LABEL (50242-922), LABEL (50242-923), PACK (50242-920), PACK (50242-921), PACK (50242-922), PACK (50242-923)
Establishment
Name Address ID/FEI Operations
Roche Diagnostics GmbH 323105205 ANALYSIS (50242-920), ANALYSIS (50242-921), ANALYSIS (50242-922), ANALYSIS (50242-923)

Revised: 03/2021 Genentech, Inc.

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