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 It was used for the treatment of atopic dermatitis in the United Kingdom but it is currently withdrawn due to lack of evidence of effectiveness.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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| EFAMOL CAP | efamol research inc. | 00551864 | Capsule - Oral | .6 ML | 12/31/1982 |
| EVENING PRIMROSE OIL WITH VITAMIN E | ashbury research corporation | 02240554 | Capsule - Oral | 500 MG / CAP | N/A |
| NAUDICELLE CAP | bio oil research ltd. | 00511188 | Capsule - Oral | 552 MG / CAP | 12/31/1981 |
| OENOTHERA BIENNIS | dolisos canada inc. | 02234636 | Liquid
,
Granules
,
Globules - Oral | 1 X | 1/5/1998 |
| NAUDICELLE OIL OF EVENING PRIMROSE | swiss herbal remedies ltd. | 00515671 | Capsule - Oral | 552 MG / CAP | 12/31/1981 |
| EVENING PRIMROSE OIL CAP | nature's way of canada ltd. | 00630578 | Capsule - Oral | 500 MG / CAP | 12/31/1984 |
| GAMMA OIL | quest vitamins a div of purity life health products | 00650277 | Capsule - Oral | 500 MG / CAP | 12/31/1985 |
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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