Overview
Oil extracted from olives . Consists primarily of the glycerides of the fatty acids linoleic, oleic and palmitic. Used as a source of fatty acids in total parenteral nutrition and as an additive in some cosmetic products .
Indication
For use in adults as a source of calories and fatty acids in total parenteral nutrition . Sometimes used as an additive in cosmetic products.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/09/18 | Phase 4 | Completed | |||
2020/06/04 | Phase 2 | Active, not recruiting | |||
2019/08/09 | Phase 1 | UNKNOWN | |||
2017/05/11 | Phase 4 | Completed | General University Hospital, Prague | ||
2016/05/03 | Phase 3 | Completed | Carola Pfeiffer-Mosesson | ||
2015/06/22 | Phase 4 | Terminated | |||
2014/07/10 | Phase 2 | Completed | |||
2013/12/12 | Phase 3 | Completed | |||
2013/09/17 | Phase 4 | Completed | Johane Allard | ||
2013/05/10 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-820 | INTRAVENOUS | 5 g in 100 mL | 8/30/2019 | |
| Baxter Healthcare Corporation | 0338-9540 | INTRAVENOUS | 16 g in 100 mL | 7/20/2016 | |
| BIOCARE PLUS INTERNATIONAL LIMITED | 85522-001 | TOPICAL | 0.47 g in 1 g | 4/9/2025 |
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 |
|---|---|---|---|---|---|
| SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION | SIN16135P | INJECTION, EMULSION | 7.2g/1000ml | 3/24/2021 | |
| SmofKabiven Emulsion for Infusion | SIN14286P | INJECTION, EMULSION | 50g /1000ml | 1/8/2013 | |
| SmofKabiven Electrolyte Free Emulsion for Infusion | SIN14292P | INJECTION, EMULSION | 50g /1000ml | 1/16/2013 | |
| SmofKabiven Peripheral Emulsion for Infusion | SIN14287P | INJECTION, EMULSION | 50g /1000ml | 1/8/2013 | |
| SMOFlipid 20% | SIN13246P | INJECTION, EMULSION | 50g per 1000ml | 4/12/2007 | |
| SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION | SIN16136P | INJECTION, EMULSION | 7.2g/1000ml | 3/24/2021 |
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 |
|---|---|---|---|---|---|
| OLIMEL N9E EMULSION FOR INFUSION | N/A | N/A | N/A | 10/24/2013 |
TGA Drug Approvals
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