Active substance
Copper
- US FDA 4
- Health Canada 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PARAGARD T 380A | 309MG/COPPER | system · intrauterine | COOPERSURGICAL | Prescription | 15 Nov 1984 |
| MIUDELLA | N/A | system · intrauterine | SEBELA WOMENS HLTH | Prescription | 24 Feb 2025 |
| CU-7 | 89MG | intrauterine device · intrauterine | GD SEARLE LLC | Discontinued | |
| TATUM-T | 120MG | intrauterine device · intrauterine | GD SEARLE LLC | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MICRO CU | 00786969 | 0.4 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
Safety signals and safety-related labeling changes
- US FDA 28 Jun 2024 PARAGARD T 380A — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
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.