Overview
Rupatadine is a dual histamine H1 receptor and platelet activating factor receptor antagonist that is used for symptomatic relief in seasonal and perennial rhinitis as well as chronic spontaneous urticaria. It was approved for marketing in Canada under the tradename Rupall and comes in tablet formulation for adult use and liquid formulation for pediatric use.
Indication
For the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 2 years of age and older . Also used for the symptomatic relief of chronic spontaneous urticaria in patients 2 years of age and older.
Associated Conditions
- Allergic Rhinitis (AR)
- Pruritus
- Urticaria
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/15 | Not Applicable | Not yet recruiting | |||
2024/12/16 | Phase 1 | Completed | |||
2024/11/27 | Phase 1 | Recruiting | |||
2022/05/02 | Phase 1 | Completed | J. Uriach and Company | ||
2020/10/23 | Phase 4 | Withdrawn | |||
2018/12/10 | Phase 3 | Recruiting | Sherief Abd-Elsalam | ||
2015/02/06 | Phase 3 | Terminated | |||
2012/05/25 | Phase 2 | Completed | |||
2005/11/24 | Phase 4 | UNKNOWN | J. Uriach and Company | ||
2005/09/20 | Phase 2 | Terminated | J. Uriach and Company |
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 |
|---|---|---|---|---|---|
| Rupafin Tablet 10mg | SIN14087P | TABLET | 10mg | 1/25/2012 | |
| RUPAFIN ORAL SOLUTION 1mg/ml | SIN14868P | SOLUTION | 1.00 mg/ml | 10/9/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rupatadine Fumarate Tablets | 国药准字H20243697 | 化学药品 | 片剂 | 5/15/2024 | |
| Rupatadine Fumarate Tablets | 国药准字H20253330 | 化学药品 | 片剂 | 1/24/2025 | |
| Rupatadine Fumarate Tablets | 国药准字HJ20200036 | 化学药品 | 片剂 | 8/26/2020 | |
| Rupatadine Fumarate Tablets | 国药准字H20244531 | 化学药品 | 片剂 | 10/15/2024 | |
| Rupatadine Fumarate Tablets | 国药准字H20249437 | 化学药品 | 片剂 | 11/22/2024 | |
| Rupatadine Fumarate Tablets | 国药准字H20243053 | 化学药品 | 片剂 | 1/16/2024 | |
| Rupatadine Fumarate Tablets | 国药准字H20140097 | 化学药品 | 片剂 | 8/12/2024 | |
| Rupatadine Fumarate Tablets | 国药准字H20249163 | 化学药品 | 片剂 | 10/22/2024 | |
| Rupatadine Fumarate Tablets | 国药准字H20244713 | 化学药品 | 片剂 | 8/20/2024 | |
| Rupatadine Fumarate Tablets | 国药准字H20173112 | 化学药品 | 片剂 | 12/6/2021 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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