HALAVEN- eribulin mesylate injection

Halaven by

Drug Labeling and Warnings

Halaven by is a Prescription medication manufactured, distributed, or labeled by BSP Pharmaceuticals SpA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

​

INGREDIENTS AND APPEARANCE

HALAVEN 
eribulin mesylate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43624-002
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ERIBULIN MESYLATE (UNII: AV9U0660CW) (ERIBULIN - UNII:LR24G6354G)	ERIBULIN MESYLATE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (clear, colorless, sterile solution for intravenous administration)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43624-002-01	100 in 1 BOX, UNIT-DOSE	04/21/2017
1		3 mL in 1 TRAY; Type 0: Not a Combination Product

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	Business Operations
BSP Pharmaceuticals SpA		857007830	manufacture(43624-002)