SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Eribulin BOS | 0.5 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 1033.15 | Generic · Prescription | Boston Oncology Arabia | Valid |
| HALAVEN | 0.44 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 1106.95 | NCE · Prescription | EISAI EUROPE LIMITED | Valid |
| HALAVEN 0.5 mg/ml | 0.5 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 2273.95 | NCE · Prescription | EISAI | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BREAST CANCER MET.HER-2 -VE; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| HALAVEN | 1MG/2ML (0.5MG/ML) | solution · intravenous | EISAI INC | Prescription | 15 Nov 2010 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | GLAND | Prescription | 5 Apr 2024 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | JIANGXI KVVIT PHARM | Prescription | 28 Jun 2024 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | LONG GROVE PHARMS | Prescription | 18 Jul 2024 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | BAXTER HLTHCARE CORP | Prescription | 1 Oct 2024 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | CHIA TAI TIANQING | Prescription | 4 Mar 2025 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | SANDOZ | Prescription | 9 Jun 2025 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | DR REDDYS | Prescription | 3 Jul 2025 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | GLENMARK PHARMS | Prescription | 5 Aug 2025 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | XGEN PHARMS | Prescription | 16 Mar 2026 |
| ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | solution · intravenous | NATCO | Prescription | 1 Jun 2026 |
EMA European Union — centrally authorised medicines
Halaven Eisai GmbH · Authorised · authorised 17 Mar 2011 · ATC L01XX41
Therapeutic indication (EMA)
Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. Halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).
Mevlyq YES Pharmaceutical Development Services GmbH · Authorised · authorised 9 Feb 2024 · ATC L01XX41
Therapeutic indication (EMA)
Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Mevlyq is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
Eribulin Baxter Baxter Holding B.V. · Authorised · authorised 27 Jun 2024 · ATC L01XX41
Therapeutic indication (EMA)
Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Eribulin Baxter is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| ERIBULIN MESYLATE INJECTION | 02545950 | 0.5 MG / ML | SOLUTION · INTRAVENOUS | DR REDDY'S LABORATORIES LTD |
| HALAVEN | 02377438 | 0.5 MG / ML | SOLUTION · INTRAVENOUS | EISAI LIMITED |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.