Active substance
Vinorelbine
- SFDA 3
- US FDA 12
- Health Canada 3
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| NAVELBINE 10MG-ML I-V VIAL | 10 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 117.50 | NCE · Prescription | PIERRE FABRE MEDICAMENT | Valid |
| NAVELBINE 10MG-ML I-V VIAL | 10 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 533.85 | NCE · Prescription | PIERRE FABRE MEDICAMENT | Valid |
| VINORELBINE ACTAVIS 50MG/5ML CONCENTRATION SOLUTION FOR INFUSION | 10 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 463.10 | NCE · Prescription | ACTAVIS | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BLADDER CANCER; BREAST CANCER MET.HER-2 +VE; BREAST CANCER MET.HER-2 -VE; Cervical Cancer; HODGKIN'S LYMPHOMA; MESOTHELIOMA; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; SALIVARY GLAND TUMORS; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; T-CELL LYMPHOMA; VAGINAL AND VULVAR CANCERS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | HIKMA PHARMS | Prescription | 10 Jun 2003 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | HIKMA PHARMS | Prescription | 11 Dec 2003 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | ACTAVIS TOTOWA | Prescription | 22 Jul 2009 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | JIANGSU HANSOH PHARM | Prescription | 26 Sep 2012 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | DR REDDYS | Prescription | 12 Sep 2013 |
| NAVELBINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | PIERRE FABRE | Discontinued | 23 Dec 1994 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | TEVA PHARMS USA | Discontinued | 3 Feb 2003 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | FRESENIUS KABI USA | Discontinued | 18 Apr 2005 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | HOSPIRA | Discontinued | 2 Jun 2005 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | EBEWE PHARMA | Discontinued | 13 Feb 2008 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | RISING | Discontinued | 31 Aug 2012 |
| VINORELBINE TARTRATE | EQ 10MG BASE/ML | injectable · injection | INGENUS PHARMS LLC | Discontinued | 5 Aug 2019 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| VINORELBINE INJECTION, USP | 02431130 | 10 MG / ML | SOLUTION · INTRAVENOUS | GENERIC MEDICAL PARTNERS INC |
| VINORELBINE INJECTION, USP | 02511347 | 10 MG / ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
| VINORELBINE TARTRATE FOR INJECTION | 02271214 | 10 MG / ML | SOLUTION · INTRAVENOUS | TEVA CANADA LIMITED |
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Rhabdomyosarcoma primary site; Other specified malignant neoplasms of bronchus or lung; Other specified malignant neoplasms of breast
Parenteral > General injections > IV: 10 mg per mL in 1 mL vial; 10 mg per mL in 5 mL vial | Oral > Solid > capsule: 20 mg; 30 mg; 80 mg (EML)
Safety signals and safety-related labeling changes
- US FDA 7 May 2019 NAVELBINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.