Halaven: Package Insert and Label Information

HALAVEN- eribulin mesylate injection
BSP Pharmaceuticals SpA

Halaven®

(eribulin mesylate) Injection, for intravenous use
1 mg/2 mL (0.5 mg/mL)

PRINCIPAL DISPLAY PANEL — SHIPPER LABEL

Eisai Manufacturing Limited

​Allegato DQA-035/XXXX​

New Chemical Entity Demand Chain Unit European Knowledge Centre

Mosquito Way-Hatfield, Herts, AL 109SN

United Kingdom

​​HALAVEN®
(eribulin mesylate) Injection, for intravenous use- 0.5mg/ml, 2 ml
Store at 15° — 25°C (59° — 77°F). DO NOT FREEZE

QTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ
(22) 900XXX MMYYYY F1XXYZZZ 7

NDC 43624-002-01

( 0X) 50X XXXXX 00X X X0 XXX

Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy.

Image (eribulin mesylate) Injection1 mg/2 mL(0.5 mg/mL)For Intravenous Use
(click image for full-size original)

HALAVEN
eribulin mesylate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43624-002
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERIBULIN MESYLATE (ERIBULIN) ERIBULIN MESYLATE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
Product Characteristics
Color white (clear, colorless, sterile solution for intravenous administration) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43624-002-01 100 TRAY in 1 BOX, UNIT-DOSE contains a TRAY
1 3 mL in 1 TRAY This package is contained within the BOX, UNIT-DOSE (43624-002-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201532 04/21/2017
Labeler — BSP Pharmaceuticals SpA (857007830)
Registrant — BSP Pharmaceuticals SpA (857007830)
Establishment
Name Address ID/FEI Operations
BSP Pharmaceuticals SpA 857007830 manufacture (43624-002)

Revised: 12/2019 BSP Pharmaceuticals SpA

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