Overview
A local anesthetic that is similar pharmacologically to lidocaine. Currently, it is used most often for infiltration anesthesia in dentistry. (From AMA Drug Evaluations Annual, 1992, p165)
Indication
适用于硬膜外麻醉、阻滞麻醉和浸润麻醉等。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/06 | Not Applicable | Completed | Istanbul Medeniyet University | ||
2025/03/28 | Not Applicable | Completed | Bursa City Hospital | ||
2025/03/28 | Not Applicable | Completed | Aynur Aytekin Ozdemir | ||
2024/09/19 | Not Applicable | Completed | |||
2024/05/16 | Not Applicable | Completed | |||
2024/03/04 | Not Applicable | Completed | |||
2024/02/23 | Not Applicable | Completed | University Hospital Waterford | ||
2023/12/11 | Phase 3 | Completed | |||
2023/11/18 | Phase 4 | Completed | |||
2023/09/05 | Phase 4 | Withdrawn | Marianne Hutti |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actavis Pharma, Inc. | 0591-2070 | TOPICAL | 25 mg in 1 g | 7/31/2019 | |
| Septodont Inc. | 0362-9014 | SUBCUTANEOUS | 40 mg in 1 mL | 10/8/2010 | |
| Dentsply Pharmaceutical | 66312-110 | PERIODONTAL | 25 mg in 1 g | 1/26/2024 | |
| Sincerus Florida, LLC | 72934-5071 | TOPICAL | 5 g in 100 g | 5/10/2019 | |
| Bryant Ranch Prepack | 63629-9604 | TOPICAL | 25 mg in 1 g | 11/22/2022 | |
| NuCare Pharamceuticals,Inc. | 68071-1625 | TOPICAL | 25 mg in 1 g | 1/28/2022 | |
| DIRECT RX | 61919-443 | TOPICAL | 25 mg in 1 g | 1/20/2020 | |
| Dentsply Pharmaceutical Inc. | 66312-540 | SUBMUCOSAL | 40 mg in 1 mL | 10/17/2017 | |
| Asclemed USA, Inc. | 76420-641 | TOPICAL | 25 mg in 1 g | 11/1/2018 | |
| Sterling-knight Pharmaceuticals,LLC | 69336-825 | TOPICAL | 25 mg in 1 g | 8/16/2016 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/15/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RACSER CREAM 5% | SIN14852P | CREAM | 2.5%w/w | 9/17/2015 | |
| TAKIPRIL SOLUTION FOR INJECTION 20MG/ML | SIN16326P | INJECTION, SOLUTION | 20.00 mg/ml | 9/17/2021 | |
| FORTACIN CUTANEOUS SPRAY SOLUTION 7.5MG/dose + 2.5MG/dose | SIN16538P | SPRAY, METERED | 2.5mg/dose | 7/5/2022 | |
| CITANEST OCTAPRESSIN INJECTION | SIN06175P | INJECTION | 66 mg/2.2 ml | 5/3/1991 | |
| EMLA CREAM 5% | SIN06443P | CREAM | 25 mg/g | 7/2/1991 |
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 |
|---|---|---|---|---|---|
| EMLA 5% CREAM (kit) | 12046 | Medicine | A | 8/13/1991 | |
| 3% CITANEST DENTAL WITH OCTAPRESSIN 2.2mL injection cartridge | 12080 | Medicine | A | 8/13/1991 | |
| Citanest 0.5% 250mg/50mL injection vial | 12079 | Medicine | A | 8/13/1991 | |
| PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule | 376271 | Medicine | A | 3/8/2023 | |
| CITANEST 2% POLYAMP DUOFIT prilocaine hydrochloride 100mg/5mL injection BP ampoule | 53722 | Medicine | A | 5/2/1996 | |
| NUMIT 5% CREAM tube | 265292 | Medicine | A | 12/3/2015 | |
| 3% CITANEST DENTAL WITH OCTAPRESSIN 2.2mL injection cartridge | 220320 | Medicine | A | 5/26/2014 | |
| EMLA 5% CREAM tube | 12886 | Medicine | A | 8/13/1991 | |
| EMLA DERMAL PATCH carton | 60820 | Medicine | A | 8/26/1997 | |
| 4% CITANEST DENTAL Prilocaine hydrochloride 88mg/2.2mL injection cartridge | 12082 | Medicine | A | 8/13/1991 |
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