Overview
Menotropins contains follicle stimulating hormone (FSH) and luteinizing hormone (LH) purified from the urine of postmenopausal women. It is used as a fertility medication that is injected either subcutaneously or intramuscularly. It is composed of LH with 2 subunits, alpha = 92 residues, beta = 121 residues and FSH with 2 subunits, alpha = 92 residues, beta=111 residues.
Background
Menotropins contains follicle stimulating hormone (FSH) and luteinizing hormone (LH) purified from the urine of postmenopausal women. It is used as a fertility medication that is injected either subcutaneously or intramuscularly. It is composed of LH with 2 subunits, alpha = 92 residues, beta = 121 residues and FSH with 2 subunits, alpha = 92 residues, beta=111 residues.
Indication
For the treatment of female infertility
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/06/04 | Not Applicable | Completed | |||
2020/05/12 | Phase 4 | UNKNOWN | |||
2019/12/10 | Not Applicable | Withdrawn | |||
2018/11/09 | Not Applicable | Completed | |||
2018/07/06 | Not Applicable | Completed | Reproductive & Genetic Hospital of CITIC-Xiangya | ||
2017/06/06 | Phase 4 | Completed | D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology | ||
2016/12/14 | Phase 4 | UNKNOWN | |||
2016/10/17 | N/A | Completed | |||
2016/07/18 | N/A | Completed | |||
2016/05/18 | Not Applicable | UNKNOWN | Navy General Hospital, Beijing |
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 |
|---|---|---|---|---|---|
| MENOPUR SOLUTION FOR INJECTION IN PRE-FILLED PEN 600 IU/0.96 ML | SIN16699P | INJECTION, SOLUTION | 600 IU | 2/20/2023 | |
| MENOPUR SOLUTION FOR INJECTION IN PRE-FILLED PEN 1200 IU/1.92 ML | SIN16700P | INJECTION, SOLUTION | 1200 IU | 2/20/2023 | |
| Menopur Powder and Solvent For Solution for Injection 75iu | SIN13356P | INJECTION, POWDER, FOR SOLUTION | 75 iu FSH 75 iu LH | 9/21/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Menotropins for Injection | 国药准字H10930134 | 化学药品 | 注射剂(冻干) | 8/5/2020 | |
| Menotropins for Injection | 国药准字H10930135 | 化学药品 | 注射剂(冻干) | 8/5/2020 | |
| Menotropins for Injection | 国药准字H10940274 | 化学药品 | 注射剂 | 1/2/2024 | |
| Menotropins for Injection | 国药准字H20023863 | 化学药品 | 注射剂(冻干) | 6/11/2020 | |
| Menotropins for Injection | 国药准字H20033108 | 化学药品 | 注射剂(冻干粉针剂) | 4/29/2020 | |
| Menotropins for Injection | 国药准字H20023864 | 化学药品 | 注射剂(冻干) | 6/11/2020 | |
| Menotropins for Injection | 国药准字H20045720 | 化学药品 | 注射剂 | 4/13/2020 | |
| Menotropins for Injection | 国药准字H20033043 | 化学药品 | 注射剂 | 7/3/2020 | |
| Menotropins for Injection | 国药准字H20033042 | 化学药品 | 注射剂 | 7/6/2020 | |
| Menotropins for Injection | 国药准字H20045721 | 化学药品 | 注射剂 | 1/8/2021 |
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 |
|---|---|---|---|---|---|
| MENOPUR gonadotrophin - human menopausal 1200IU multidose powder for injection vial with diluent syringe | 161985 | Medicine | A | 9/13/2011 | |
| MENOPUR human menopausal gonadotrophin 1200 IU/1.92 mL solution for injection pre-filled multidose pen | 354652 | Medicine | A | 1/24/2022 | |
| MENOPUR gonadotrophin - human menopausal 600IU multidose powder for injection vial with diluent syringe | 161984 | Medicine | A | 9/13/2011 | |
| MENOPUR human menopausal gonadotrophin 600 IU/0.96 mL solution for injection pre-filled multidose pen | 354650 | Medicine | A | 1/24/2022 |