Active substance
Primaquine
- US FDA 4
- Health Canada 1
- WHO EML 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PRIMAQUINE | EQ 15MG BASE | tablet · oral | SANOFI AVENTIS US | Prescription | 23 Jan 1952 |
| PRIMAQUINE PHOSPHATE | EQ 15MG BASE | tablet · oral | UNICHEM | Prescription | 25 Feb 2014 |
| PRIMAQUINE PHOSPHATE | EQ 15MG BASE | tablet · oral | INGENUS PHARMS LLC | Prescription | 23 Jun 2016 |
| PRIMAQUINE PHOSPHATE | EQ 15MG BASE | tablet · oral | ALVOGEN | Discontinued | 3 Feb 2014 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| PRIMAQUINE | 02017776 | 26.3 MG | TABLET · ORAL | SANOFI-AVENTIS CANADA INC |
WHO WHO Model List of Essential Medicines (2025)
- 6.5.3.1. Antimalarial medicines > Medicines for curative treatment · core
Malaria due to Plasmodium ovale; Malaria due to Plasmodium falciparum; Malaria due to Plasmodium vivax
Oral > Solid > tablet: 7.5 mg (as phosphate); 15 mg (as phosphate)
Safety signals and safety-related labeling changes
- US FDA 2 Feb 2026 PRIMAQUINE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions
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.