Overview
Rivastigmine is a parasympathomimetic or cholinergic agent for the treatment of mild to moderate dementia of the Alzheimer's type. Rivastigmine is a cholinesterase inhibitor that inhibits both butyrylcholinesterase and acetylcholinesterase.
Background
Rivastigmine is a parasympathomimetic or cholinergic agent for the treatment of mild to moderate dementia of the Alzheimer's type. Rivastigmine is a cholinesterase inhibitor that inhibits both butyrylcholinesterase and acetylcholinesterase.
Indication
For the treatment of mild to moderate dementia associated with Parkinson's disease or of the Alzheimer's type.
Associated Conditions
- Dementia With Lewy Body Disease
- Mild Dementia due to Parkinson's disease
- Mild Dementia of the Alzheimer's Type
- Moderate Alzheimer's Type Dementia
- Moderate Dementia due to Parkinson's disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/05 | Phase 2 | Recruiting | |||
2024/05/06 | Phase 2 | Recruiting | |||
2024/04/24 | Phase 2 | Not yet recruiting | |||
2023/05/31 | Phase 1 | Completed | SocraTec R&D GmbH | ||
2023/05/10 | Phase 1 | Completed | |||
2023/03/14 | Phase 4 | Recruiting | |||
2020/04/29 | Early Phase 1 | Recruiting | |||
2020/01/13 | Phase 3 | Active, not recruiting | |||
2019/12/06 | Phase 1 | Completed | |||
2019/05/21 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Chartwell RX, LLC | 62135-900 | ORAL | 1.5 mg in 1 1 | 10/6/2023 | |
| Breckenridge Pharmaceutical, Inc | 51991-796 | ORAL | 6 mg in 1 1 | 4/28/2022 | |
| Breckenridge Pharmaceutical, Inc | 51991-795 | ORAL | 4.5 mg in 1 1 | 4/28/2022 | |
| Sun Pharmaceutical Industries, Inc. | 62756-146 | ORAL | 3 mg in 1 1 | 1/31/2019 | |
| Bryant Ranch Prepack | 72162-1608 | TRANSDERMAL | 4.6 mg in 24 h | 8/30/2023 | |
| Ajanta Pharma Limited | 27241-092 | ORAL | 4.5 mg in 1 1 | 2/19/2018 | |
| Alembic Pharmaceuticals Inc. | 62332-063 | ORAL | 1.5 mg in 1 1 | 4/7/2022 | |
| Rebel Distributors Corp | 21695-357 | TRANSDERMAL | 4.6 mg in 24 [USP'U] | 3/24/2010 | |
| Alembic Pharmaceuticals Inc. | 62332-064 | ORAL | 3 mg in 1 1 | 4/7/2022 | |
| Bryant Ranch Prepack | 63629-2065 | TRANSDERMAL | 4.6 mg in 24 h | 12/20/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/11/1998 | ||
Authorised | 5/11/2009 | ||
Authorised | 12/11/2009 | ||
Authorised | 12/10/2009 | ||
Authorised | 12/4/1998 | ||
Authorised | 12/11/2009 | ||
Authorised | 12/10/2009 | ||
Authorised | 12/11/2009 | ||
Authorised | 12/11/2009 | ||
Authorised | 12/4/1998 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Exelon Patch 5 (4.6mg/24hr) | SIN13450P | PATCH, EXTENDED RELEASE | 9mg/5cm2 | 4/28/2008 | |
| EXELON PATCH 15 (13.3mg/24hr) | SIN14500P | PATCH, EXTENDED RELEASE | 27.000 mg | 2/5/2014 | |
| EXELON CAPSULE 3 mg | SIN10036P | CAPSULE | 3 mg | 9/24/1998 | |
| EXELON CAPSULE 4.5 mg | SIN10037P | CAPSULE | 4.5 mg | 9/24/1998 | |
| Exelon Patch 10 (9.5mg/24hr) | SIN13451P | PATCH, EXTENDED RELEASE | 18.00mg/10cm2 | 4/28/2008 | |
| EXELON CAPSULE 1.5 mg | SIN10035P | CAPSULE | 1.5 mg | 9/24/1998 | |
| EXELON CAPSULE 6 mg | SIN10038P | CAPSULE | 6 mg | 9/24/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rivastigmine Bitartrate Oral Solution | 国药准字H20249583 | 化学药品 | 口服溶液剂 | 12/1/2024 | |
| Rivastigmine Bitartrate Oral Solution | 国药准字H20244630 | 化学药品 | 口服溶液剂 | 8/5/2024 | |
| Rivastigmine Bitartrate Oral Solution | 国药准字H20244273 | 化学药品 | 口服溶液剂 | 6/28/2024 | |
| Rivastigmine Transdermal Patch | 国药准字H20244948 | 化学药品 | 贴剂 | 9/19/2024 | |
| Rivastigmine Transdermal Patch | 国药准字HJ20200018 | 化学药品 | 贴剂 | 3/25/2025 | |
| Rivastigmine Transdermal Patch | 国药准字HJ20200019 | 化学药品 | 贴剂 | 3/25/2025 | |
| Rivastigmine Transdermal Patch | 国药准字HJ20230123 | 化学药品 | 贴剂 | 10/27/2023 | |
| Rivastigmine Transdermal Patch | H20200019 | 化学药品 | 贴剂 | 6/2/2020 | |
| Rivastigmine Transdermal Patch | 国药准字HJ20230124 | 化学药品 | 贴剂 | 10/27/2023 | |
| Rivastigmine Transdermal Patch | H20200018 | 化学药品 | 贴剂 | 6/2/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||