Active substance
Biotin
- SFDA 1
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| BioVitin | 10 mg | Tablet · Oral use | 100 Bottle | SAR 61.05 | NCE · OTC | ARNET PHARMACEUTICAL CORP | Valid |
Safety signals and safety-related labeling changes
- US FDA 6 Nov 2024 INFUVITE ADULT — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 6 Nov 2024 INFUVITE PEDIATRIC — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 16 Dec 2020 M.V.I. ADULT — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 17 Jan 2019 PRAC signal: Interference with clinical laboratory tests
Action for MAH: update of the product information: Yes - EMA PRAC 14 Jun 2018 PRAC signal: Interference with clinical laboratory tests
Action for MAH: update of the product information: No - EMA PRAC 8 Feb 2018 PRAC signal: Interference with clinical laboratory tests
Action for MAH: update of the product information: No - US FDA 9 Nov 2017 M.V.I. ADULT (PHARMACY BULK PACKAGE) — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Nov 2017 M.V.I.-12 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; 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.