Overview
Evening primrose oil comes from the extraction from Oenothera biennis seeds and it is commonly used as an alternative source for omega-6 essential fatty acids. In its composition it presents some fatty acids such as Linolenic acid and Gamolenic acid. Evening primrose oil has been filled for the FDA by Humanetics Corporation on April 2000 to be a new dietary ingredient but its current status is "Inadequate basis for expectation of safety". By Health Canada, evening primrose oil is approved in over-the-counter combination dietary supplements. By the EMA, evening primrose oil is approved in herbal preparations.
Indication
Evening primrose oil is used as part of over-the-counter dietary supplements. It is also used for the treatment of systemic inflammatory diseases and for women's health conditions such as cyclical mastalgia. These indications do not have sufficient evidence of their effectiveness. It was used for the treatment of atopic dermatitis in the United Kingdom but it is currently withdrawn due to lack of evidence of effectiveness.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2009/10/22 | Phase 4 | Completed | Medical College and Hospital Kolkata |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Oenothera Biennis Oil Soft Capsules | 国药准字H21023036 | 化学药品 | 软胶囊剂 | 3/9/2020 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H45021034 | 化学药品 | 胶囊剂 | 8/12/2020 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H11021932 | 化学药品 | 胶囊剂 | 7/22/2024 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H23022673 | 化学药品 | 胶囊剂(软胶囊) | 5/15/2020 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H22025773 | 化学药品 | 软胶囊剂 | 4/25/2020 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H20058370 | 化学药品 | 胶囊剂 | 7/14/2021 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H44024507 | 化学药品 | 胶囊剂 | 6/28/2019 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H32026127 | 化学药品 | 胶囊剂 | 8/11/2020 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H35021221 | 化学药品 | 胶囊剂(软胶囊) | 2/25/2020 | |
| Oenothera Biennis Oil Soft Capsules | 国药准字H13023700 | 化学药品 | 胶囊剂(软胶囊) | 3/18/2020 |
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 |
|---|---|---|---|---|---|
| Top Life Evening Primrose Oil 1000 Max | 110300 | Medicine | A | 9/28/2004 | |
| Spring Leaf Evening Primrose Oil 1000mg | 110298 | Medicine | A | 9/28/2004 | |
| EVENING PRIMROSE OIL 1000 mg | 81108 | Medicine | A | 12/4/2001 | |
| PREMEO | 172667 | Medicine | A | 6/29/2010 | |
| YHL EVENING PRIMROSE OIL 1000MG | 351317 | Medicine | A | 12/9/2020 | |
| Eposoft | 338215 | Medicine | A | 6/22/2020 | |
| Women's Health plus | 455586 | Medicine | A | 7/18/2024 | |
| EFA Krill | 422250 | Medicine | A | 9/22/2023 | |
| WEALTHY HEALTH DHA - SUPER 45 COMPLEX | 70672 | Medicine | A | 8/13/1999 | |
| Wealthy Health R.J. Plus | 125152 | Medicine | A | 1/18/2006 |
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