Overview
Norgestrel is synthetic steroidal progestin that is used in combination with ethinyl estradiol for oral contraception. Norgestrel is composed of a racemic mixture of two stereoisomers, dextronorgestrel and levonorgestrel. However, only the levorotary enantiomer (levonorgestrel) is biologically active.
Indication
Norgestrel in combination with ethinyl estradiol is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Associated Conditions
- Abnormal Uterine Bleeding
- Endometriosis
- Hypermenorrhea
- Menstrual Distress (Dysmenorrhea)
- Polycystic Ovarian Syndrome (PCOS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/10/02 | Phase 3 | Completed | HRA Pharma | ||
2018/07/13 | Phase 2 | Completed | HRA Pharma | ||
2018/06/15 | Phase 3 | Terminated | HRA Pharma | ||
2003/01/27 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| PROGYLUTON TABLET | SIN04778P | TABLET, SUGAR COATED | 0.5 mg | 6/25/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Norgestrel Tablets | 国药准字H11022262 | 化学药品 | 片剂 | 11/26/2020 | |
| Norgestrel Tablets | 国药准字H11022128 | 化学药品 | 片剂 | 11/14/2023 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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