Active substance
Onabotulinumtoxina
- US FDA 2
- Health Canada 4
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BOTOX | 50 UNITS/VIAL; 100 UNITS/VIAL; 200 UNITS/VIAL | vial · single-use | ALLERGAN | Prescription | 9 Dec 1991 |
| BOTOX COSMETIC | 50 UNITS/VIAL; 100 UNITS/VIAL | vial · single-use | ALLERGAN | Prescription | 9 Dec 1991 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| BOTOX | 01981501 | 100 UNIT / VIAL | POWDER FOR SOLUTION · INTRADERMAL; INTRADETRUSORIAL; INTRAMUSCULAR | ABBVIE CORPORATION |
| BOTOX | 02531577 | 50 UNIT / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR; INTRADERMAL; INTRADETRUSORIAL | ABBVIE CORPORATION |
| BOTOX | 02531585 | 200 UNIT / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR; INTRADETRUSORIAL; INTRADERMAL | ABBVIE CORPORATION |
| BOTOX COSMETIC | 02243721 | 100 UNIT / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR | ABBVIE CORPORATION |
Safety signals and safety-related labeling changes
- US FDA 18 Oct 2024 BOTOX — safety-related labeling change
Labeling sections changed: Contraindications; 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.