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  • Halaven ERIBULIN MESYLATE .5 mg/mL BSP Pharmaceuticals SpA
FDA Drug information

Halaven

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20231122

Version

51

Spl Product Data Elements

Halaven eribulin mesylate ALCOHOL WATER ERIBULIN MESYLATE ERIBULIN clear, colorless, sterile solution for intravenous administration

Application Number

NDA201532

Brand Name

Halaven

Generic Name

eribulin mesylate

Product Ndc

43624-002

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

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

Spl Unclassified Section

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

Drug section

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