Overview
An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404)
Indication
For the treatment of malaria.
Associated Conditions
- Malaria
- Malaria caused by Plasmodium ovale
- Malaria caused by plasmodium vivax
- Pneumocystis Jirovecii Pneumonia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/30 | Phase 3 | Recruiting | |||
2024/03/06 | Phase 1 | Completed | |||
2024/01/05 | Phase 4 | Completed | |||
2023/11/28 | Phase 3 | Recruiting | |||
2023/09/21 | Phase 4 | Completed | Dinka Dugassa | ||
2023/09/13 | Phase 2 | Completed | Syamsudin Abdillah,Ph.D, Pharm D | ||
2023/07/25 | N/A | Completed | Research Institute for Tropical Medicine, Philippines | ||
2023/07/25 | N/A | Completed | Research Institute for Tropical Medicine, Philippines | ||
2023/07/24 | N/A | Completed | Research Institute for Tropical Medicine, Philippines | ||
2023/04/25 | Phase 2 | Completed | Syamsudin Abdillah,Ph.D, Pharm D |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvKARE | 42291-510 | ORAL | 15 mg in 1 1 | 1/9/2024 | |
| Bayshore Pharmaceuticals, LLC | 76385-102 | ORAL | 15 mg in 1 1 | 1/17/2020 | |
| Ingenus Pharmaceuticals, LLC | 50742-191 | ORAL | 15 mg in 1 1 | 1/31/2018 | |
| Aidarex Pharmaceuticals LLC | 33261-671 | ORAL | 15 mg in 1 1 | 9/8/2017 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-721 | ORAL | 15 mg in 1 1 | 5/19/2023 | |
| Sanofi-Aventis U.S. LLC | 0024-1596 | ORAL | 15 mg in 1 1 | 8/21/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PRIMACIN primaquine (as phosphate) 7.5mg tablet bottle | 226430 | Medicine | A | 11/10/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PRIMAQUINE | sanofi-aventis canada inc | 02017776 | Tablet - Oral | 26.3 MG | 12/31/1945 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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