Overview
Propofol is an intravenous anaesthetic agent used for induction and maintenance of general anaesthesia. IV administration of propfol is used to induce unconsciousness after which anaesthesia may be maintained using a combination of medications. Recovery from propofol-induced anaesthesia is generally rapid and associated with less frequent side effects (e.g. drowsiness, nausea, vomiting) than with thiopental, methohexital, and etomidate. Propofol may be used prior to diagnostic procedures requiring anaesthesia, in the management of refractory status epilepticus, and for induction and/or maintenance of anaesthesia prior to and during surgeries.
Indication
Used for induction and/or maintenance of anaesthesia and for management of refractory status epilepticus.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/25 | Phase 2 | Not yet recruiting | |||
2025/06/24 | Not Applicable | Completed | Ataturk Training and Research Hospital | ||
2025/06/19 | Phase 4 | Not yet recruiting | |||
2025/06/13 | Not Applicable | Recruiting | |||
2025/06/03 | Phase 4 | Not yet recruiting | |||
2025/05/25 | Not Applicable | Not yet recruiting | Second Hospital of Shanxi Medical University | ||
2025/05/22 | Not Applicable | Recruiting | |||
2025/05/16 | Not Applicable | Active, not recruiting | Northern Jiangsu People's Hospital | ||
2025/05/06 | Not Applicable | Completed | |||
2025/05/01 | Phase 4 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Reddy's Laboratories, Inc. | 43598-548 | INTRAVENOUS | 10 mg in 1 mL | 9/30/2022 | |
| General Injectables & Vaccines, Inc | 52584-269 | INTRAVENOUS | 10 mg in 1 mL | 1/18/2017 | |
| Sagent Pharmaceuticals | 25021-608 | INTRAVENOUS | 10 mg in 1 mL | 2/3/2023 | |
| A-S Medication Solutions | 50090-4569 | INTRAVENOUS | 10 mg in 1 mL | 2/29/2020 | |
| Fresenius Kabi USA, LLC | 63323-269 | INTRAVENOUS | 10 mg in 1 mL | 9/15/2023 | |
| Hospira, Inc. | 0409-6010 | INTRAVENOUS | 10 mg in 1 mL | 2/14/2023 | |
| Hospira, Inc. | 0409-4699 | INTRAVENOUS | 10 mg in 1 mL | 2/14/2023 | |
| Amneal Pharmaceuticals Private Limited | 80830-2365 | INTRAVENOUS | 10 mg in 1 mL | 5/20/2025 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6196 | INTRAVENOUS | 10 mg in 1 mL | 11/18/2022 | |
| Fresenius Kabi USA, LLC | 63323-269 | INTRAVENOUS | 10 mg in 1 mL | 3/24/2023 |
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 |
|---|---|---|---|---|---|
| Recofol N 10mg/ml Emulsion for injection or infusion | B.Braun Melsungen AG | SIN08801P | INJECTION | 10 mg/ml | 7/3/1996 |
| Propofol-Lipuro 2% (20mg/ml) | SIN13622P | EMULSION | 20.0mg/ml | 3/23/2009 | |
| FRESOFOL MCT/LCT (PROPOFOL) EMULSION FOR INJECTION OR INFUSION 2% | SIN12472P | EMULSION | 2% | 12/5/2003 | |
| Recofol N 20mg/ml Emulsion for injection or infusion | B.Braun Melsungen AG | SIN11754P | INJECTION | 20 mg/ml | 1/3/2002 |
| PROPOFOL-LIPURO INJECTION 1% w/v | SIN12266P | EMULSION | 10 mg/ml | 4/25/2003 | |
| FRESOFOL MCT/LCT EMULSION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE 2% | SIN15592P | INJECTION, EMULSION | 20mg/ml | 12/4/2018 | |
| PROPOFOL 1% MCT/LCT FRESENIUS EMULSION FOR INJECTION OR INFUSION | SIN11577P | INJECTION | 1% | 7/4/2001 | |
| BAXTER PROPOFOL MCT-LCT EMULSION FOR INJECTION OR INFUSION 1% W/V | SIN17047P | INJECTION, EMULSION | 10 mg/ml | 7/19/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Propofol Injectable Emulsion | 国药准字H20234180 | 化学药品 | 注射剂 | 9/19/2023 | |
| Propofol Injectable Emulsion | 国药准字H20040300 | 化学药品 | 注射剂 | 5/28/2020 | |
| Propofol Injectable Emulsion | 国药准字HJ20171277 | 化学药品 | 注射剂 | 12/20/2024 | |
| Propofol Injectable Emulsion | 国药准字HJ20171275 | 化学药品 | 注射剂 | 12/20/2024 | |
| Propofol Injectable Emulsion | 国药准字HJ20171273 | 化学药品 | 注射剂 | 12/20/2024 | |
| Propofol Injectable Emulsion | 国药准字HJ20171278 | 化学药品 | 注射剂 | 12/20/2024 | |
| Propofol Injectable Emulsion | 国药准字HJ20170311 | 化学药品 | 注射剂 | 11/4/2021 | |
| Propofol Injectable Emulsion | 国药准字H20030115 | 化学药品 | 注射剂(注射液) | 9/4/2020 | |
| Propofol Injectable Emulsion | 国药准字HJ20170305 | 化学药品 | 注射剂 | 11/4/2021 | |
| Propofol Injectable Emulsion | 国药准字H20163405 | 化学药品 | 注射剂 | 12/26/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML | N/A | N/A | N/A | 7/3/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PROPOFOL-LIPURO 1% propofol 1000 mg/100 mL emulsion for injection bottle | 220081 | Medicine | A | 3/10/2015 | |
| ANESIA propofol 1000mg/100mL emulsion for injection vial | 153585 | Medicine | A | 5/22/2009 | |
| ANESIA propofol 200mg/20mL emulsion for injection vial | 153210 | Medicine | A | 5/22/2009 | |
| DIPRIVAN propofol 200mg/20mL injection vial | 77251 | Medicine | A | 2/9/2001 | |
| PROVIVE 1% propofol 1000mg/100mL emulsion for injection vial | 118940 | Medicine | A | 5/6/2005 | |
| PROVIVE 1% propofol 500mg/50mL emulsion for injection vial | 118939 | Medicine | A | 5/6/2005 | |
| PROPOFOL-LIPURO 2% propofol 1000 mg/50 mL emulsion for injection bottle | 220084 | Medicine | A | 3/10/2015 | |
| Fresofol 1% MCT/LCT Propofol 500mg/50mL Emulsion for Intravenous Injection/Infusion vial | 193609 | Medicine | A | 11/23/2012 | |
| PROPOFOL-LIPURO 1% propofol 200 mg/20 mL emulsion for injection vial | 220082 | Medicine | A | 3/10/2015 | |
| PROPOFOL-LIPURO 1% propofol 500 mg/50 mL emulsion for injection bottle | 220083 | Medicine | A | 3/10/2015 |
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