Overview
A nonsteroidal abortifacient agent that is effective in both the first and second trimesters of pregnancy.
Background
A nonsteroidal abortifacient agent that is effective in both the first and second trimesters of pregnancy.
Indication
For aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Also for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management.
Associated Conditions
- Unresponsive Postpartum Haemorrhage (PPH) caused by Uterine Atony
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/29 | Not Applicable | Recruiting | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2023/04/28 | Not Applicable | Completed | |||
2022/08/29 | Early Phase 1 | Recruiting | |||
2016/08/10 | Not Applicable | Completed | Dongyu Wang | ||
2013/06/05 | Not Applicable | Completed | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2009/10/02 | Not Applicable | Completed | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Reddy's Laboratories Inc. | 43598-179 | INTRAMUSCULAR | 250 ug in 1 mL | 6/30/2023 | |
| Xellia Pharmaceuticals USA LLC | 70594-112 | INTRAMUSCULAR | 250 ug in 1 mL | 11/1/2023 | |
| Gland Pharma Limited | 68083-584 | INTRAMUSCULAR | 250 ug in 1 mL | 8/8/2023 | |
| Caplin Steriles Limited | 65145-132 | INTRAMUSCULAR | 250 ug in 1 mL | 2/22/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1680 | INTRAMUSCULAR | 250 ug in 1 mL | 12/23/2023 | |
| SOLA Pharmaceuticals, LLC | 70512-859 | INTRAMUSCULAR | 250 ug in 1 mL | 9/25/2023 | |
| Alembic Pharmaceuticals Limited | 46708-777 | INTRAMUSCULAR | 250 ug in 1 mL | 3/15/2024 | |
| Long Grove Pharmaceuticals, LLC | 81298-5010 | INTRAMUSCULAR | 250 ug in 1 mL | 10/19/2022 | |
| Alembic Pharmaceuticals Inc. | 62332-777 | INTRAMUSCULAR | 250 ug in 1 mL | 4/22/2022 | |
| Pharmacia & Upjohn Company LLC | 0009-0856 | INTRAMUSCULAR | 250 ug in 1 mL | 1/10/2022 |
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 |
|---|---|---|---|---|---|
| HEMABATE INJECTION 250 mcg/ml | SIN06722P | INJECTION | 250 mcg/ml | 11/29/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Carboprost Tromethamine Injection | 国药准字H20253565 | 化学药品 | 注射剂 | 3/4/2025 | |
| Carboprost Tromethamine Injection | 国药准字H20244160 | 化学药品 | 注射剂 | 6/25/2024 | |
| Carboprost Tromethamine Injection | 国药准字H20244516 | 化学药品 | 注射剂 | 7/30/2024 | |
| Carboprost Tromethamine Injection | 国药准字H20223039 | 化学药品 | 注射剂 | 1/30/2022 | |
| Carboprost Tromethamine Injection | 国药准字H20094183 | 化学药品 | 注射剂 | 12/3/2019 | |
| Carboprost Tromethamine Injection | 国药准字H20234616 | 化学药品 | 注射剂 | 12/5/2023 | |
| Carboprost Tromethamine Injection | 国药准字H20249651 | 化学药品 | 注射剂 | 12/1/2024 | |
| Carboprost Tromethamine Injection | 国药准字HJ20230043 | 化学药品 | 注射剂 | 4/28/2023 | |
| Carboprost Tromethamine Injection | 国药准字H20234455 | 化学药品 | 注射剂 | 10/30/2023 | |
| Carboprost Tromethamine Injection | 国药准字H20243336 | 化学药品 | 注射剂 | 3/12/2024 |
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 |
|---|---|---|---|---|---|
| CARBOPROST-REACH carboprost (as trometamol) 250 microgram/1 mL solution for injection vial | 394092 | Medicine | A | 6/30/2023 | |
| CARBOPROST DR.REDDY'S carboprost (as trometamol) 250 microgram /1 mL injection vial | 387952 | Medicine | A | 5/2/2023 |