Active substance
Histrelin
- US FDA 3
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SUPPRELIN LA | 50MG | implant · subcutaneous | ENDO OPERATIONS | Prescription | 3 May 2007 |
| SUPPRELIN | EQ 0.2MG BASE/ML; EQ 0.5MG BASE/ML; EQ 1MG BASE/ML | injectable · injection | SHIRE | Discontinued | 24 Dec 1991 |
| VANTAS | 50MG | implant · subcutaneous | ENDO OPERATIONS | Discontinued | 12 Oct 2004 |
Safety signals and safety-related labeling changes
- US FDA 6 May 2026 VANTAS — 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 23 Sep 2025 SUPPRELIN LA — 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.