Active substance
Telavancin
- SFDA 2
- US FDA 3
- EMA 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| VIBATIV | 750 mg | Lyophilisate for solution for infusion · Intravenous use | 1 Vial | SAR 511.20 | NCE · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| VIBATIV (10 vials) | 750 mg | Lyophilisate for solution for infusion · Intravenous use | 10 Vial | SAR 5111.90 | NCE · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
Indications — CHI Daman Drug Formulary
BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES)
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Vibativ Theravance Biopharma Ireland Umited · Withdrawn · authorised 2 Sep 2011 · ATC J01XA03
Therapeutic indication (EMA)
Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety signals and safety-related labeling changes
- US FDA 7 Jul 2020 VIBATIV — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; 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.