Active substance
Hyaluronidase
- US FDA 4
- EMA 1
- Safety 6
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| VITRASE | 200 UNITS/VIAL | injectable · injection | BAUSCH AND LOMB | Prescription | 5 May 2004 |
| AMPHADASE | 150 UNITS/ML | injectable · injection | AMPHASTAR PHARM | Prescription | 26 Oct 2004 |
| VITRASE | 6,200 UNITS/VIAL | injectable · injection | BAUSCH AND LOMB | Discontinued | 5 May 2004 |
| HYDASE | 150 UNITS/ML | injectable · injection | AKORN INC | Discontinued | 25 Oct 2005 |
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 12 May 2026 OPDIVO QVANTIG — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Jan 2026 DARZALEX FASPRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Aug 2024 AMPHADASE — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations - US FDA 18 Jun 2024 HERCEPTIN HYLECTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations - US FDA 10 Jun 2021 RITUXAN HYCELA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 May 2018 VITRASE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Hyaluronidase
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.