Halaven®
(eribulin mesylate) Injection, for intravenous use
1 mg/2 mL (0.5 mg/mL)
Halaven Injection
FDA Label NDC 43624-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bsp Pharmaceuticals Spa for the product Halaven (NDC 43624-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding halaven®, principal display panel - shipper label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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