Overview
Dinoprostone is a naturally occurring prostaglandin E2 (PGE2). It has important effects in labour. It also stimulates osteoblasts to release factors which stimualtes bone resorption by osteoclasts. As a prescription drug it is used as a vaginal suppository, to prepare the cervix for labour and to induce labour.
Indication
For the termination of pregnancy during the second trimester (from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period), as well as for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. Also used in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). Other indications include improving the cervical inducibility (cervical "ripening") in pregnant women at or near term with a medical or obstetrical need for labor induction, and the management of postpartum hemorrhage.
Associated Conditions
- Gestational Trophoblastic Neoplasia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/19 | Not Applicable | Completed | |||
2024/04/15 | Phase 3 | Recruiting | Hospital Universitario 12 De Octubre | ||
2023/03/09 | Phase 3 | Completed | |||
2022/06/24 | Phase 4 | UNKNOWN | |||
2022/04/22 | Phase 2 | Completed | National University of Malaysia | ||
2021/02/10 | Not Applicable | Recruiting | |||
2020/10/22 | Not Applicable | Completed | |||
2020/08/05 | Not Applicable | UNKNOWN | Aswan University Hospital | ||
2020/06/04 | Phase 2 | Completed | University Hospital Center of Martinique | ||
2020/04/22 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pharmacia and Upjohn Company LLC | 0009-3359 | VAGINAL | 0.5 mg in 3 g | 12/11/2019 | |
| Ferring Pharmaceuticals Inc. | 55566-2800 | VAGINAL | 10 mg in 241 mg | 1/31/2020 |
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 |
|---|---|---|---|---|---|
| PROSTIN E2 VAGINAL TABLET 3 mg | SIN02520P | TABLET | 3 mg | 4/17/1989 | |
| Cervidil Vaginal Delivery System 10mg | SIN13982P | OTHER | 10mg | 7/4/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Prostaglandin E2 Solution | 国药准字H41025219 | 化学药品 | 注射剂 | 7/9/2020 | |
| Prostaglandin E2 Solution | 国药准字H41025218 | 化学药品 | 注射剂 | 7/15/2020 | |
| Dinoprostone Suppositories | 国药准字HJ20140332 | 化学药品 | 栓剂 | 1/31/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PROSTIN E2 STERILE SOLN 10MG/ML | N/A | N/A | N/A | 11/20/1980 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CERVIDIL dinoprostone 10 mg pessary sachet | 81391 | Medicine | A | 1/11/2002 | |
| PROSTIN E2 VAGINAL GEL 2mg | 9984 | Medicine | A | 8/27/1991 | |
| PROSTIN E2 VAGINAL GEL 1mg | 9983 | Medicine | A | 8/27/1991 |
Help Us Improve
Your feedback helps us provide better drug information and insights.