Active substance
Abobotulinumtoxina
- US FDA 1
- Health Canada 3
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DYSPORT | 500 UNITS/VIAL; 300 UNITS/VIAL | injectable · injection | IPSEN BIOPHARM LTD | Prescription | 29 Apr 2009 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| DYSPORT AESTHETIC | 02387735 | 300 UNIT / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR | IPSEN BIOPHARMACEUTICALS CANADA INC |
| DYSPORT THERAPEUTIC | 02456117 | 500 UNIT / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR | IPSEN BIOPHARMACEUTICALS CANADA INC |
| DYSPORT THERAPEUTIC | 02460203 | 300 UNIT / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR | IPSEN BIOPHARMACEUTICALS CANADA INC |
Safety signals and safety-related labeling changes
- US FDA 21 Sep 2023 DYSPORT — 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.