HALAVEN- eribulin mesylate injection 
BSP Pharmaceuticals SpA

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HALAVEN®(eribulin mesylate) injection 0.5 mg/mL

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.

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Image (eribulin mesylate) Injection1 mg/2 mL(0.5 mg/mL)For Intravenous Use

HALAVEN 
eribulin mesylate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43624-002
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERIBULIN MESYLATE (UNII: AV9U0660CW) (ERIBULIN - UNII:LR24G6354G) ERIBULIN MESYLATE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (clear, colorless, sterile solution for intravenous administration) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43624-002-01100 in 1 BOX, UNIT-DOSE04/21/2017
13 mL in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20153204/21/2017
Labeler - BSP Pharmaceuticals SpA (857007830)
Registrant - BSP Pharmaceuticals SpA (857007830)
Establishment
NameAddressID/FEIBusiness Operations
BSP Pharmaceuticals SpA857007830manufacture(43624-002)

Revised: 11/2023
Document Id: 0ac2e24a-5da3-6e69-e063-6394a90a0af1
Set id: 8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6
Version: 51
Effective Time: 20231122
 
BSP Pharmaceuticals SpA