Overview
Ambroxol is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus. It is the active ingredient of Mucosolvan, Lasolvan or Mucoangin. The substance is a mucoactive drug with several properties including secretolytic and secretomotoric actions that restore the physiological clearance mechanisms of the respiratory tract which play an important role in the body’s natural defence mechanisms. It stimulates synthesis and release of surfactant by type II pneumocytes. Surfactants acts as an anti-glue factor by reducing the adhesion of mucus to the bronchial wall, in improving its transport and in providing protection against infection and irritating agents.
Indication
Ambroxol is indicated for secretolytic therapy in bronchoplmonary disease with abnormal mucus secretion and transport. It allows the mucus to be more easily cleared and ease a patient's breathing.
Associated Conditions
No associated conditions information available.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/05/28 | Phase 1 | Not yet recruiting | |||
2019/05/15 | Phase 2 | Completed | |||
2019/02/18 | Phase 3 | Completed | |||
2018/07/11 | Phase 3 | Completed | |||
2018/01/30 | Phase 2 | Completed | |||
2016/10/21 | Phase 2 | Completed | |||
2016/09/26 | Phase 2 | Active, not recruiting | |||
2015/10/09 | Phase 1 | Completed | |||
2014/07/18 | Phase 1 | Completed | |||
2014/07/18 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ambroxol Hydrochloride Syrup | 国药准字H20066292 | 化学药品 | 糖浆剂 | 4/8/2024 | |
| Ambroxol Hydrochloride Sustained-release Tablets | 国药准字H20080643 | 化学药品 | 片剂 | 4/7/2023 | |
| Ambroxol Hydrochloride Spray | 国药准字H20227116 | 化学药品 | 喷雾剂 | 9/16/2022 | |
| Ambroxol Hydrochloride Spray | gmep medical technology gmbh | 国药准字HJ20240130 | 化学药品 | 喷雾剂 | 11/15/2024 |
| Ambroxol Hydrochloride Spray | 国药准字H20227115 | 化学药品 | 喷雾剂 | 9/16/2022 | |
| Ambroxol Hydrochloride Spray | 国药准字H20210037 | 化学药品 | 喷雾剂 | 7/28/2021 | |
| Ambroxol Hydrochloride Dispersible Tablets | 国药准字H20052313 | 化学药品 | 片剂（分散片） | 3/13/2020 | |
| Ambroxol Hydrochloride Dispersible Tablets | 国药准字H20060369 | 化学药品 | 片剂 | 5/11/2021 | |
| Ambroxol Hydrochloride Dispersible Tablets | 国药准字H20060254 | 化学药品 | 片剂 | 8/17/2020 | |
| Ambroxol Hydrochloride Dispersible Tablets | 国药准字H20100188 | 化学药品 | 片剂 | 2/3/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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