This brand name is authorized in Ecuador, Mexico, Nigeria, South Africa, Tunisia.
The drug APROVASC contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
J0E2756Z7N - IRBESARTAN
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Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. |
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2
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UNII
864V2Q084H - AMLODIPINE BESYLATE
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Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| APROVASC Film-coated tablet | MPI, Generic | Marketing Authorisation Holder |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| C09DB05 | Irbesartan and amlodipine | C Cardiovascular system → C09 Agents acting on the renin-angiotensin system → C09D Angiotensin II antagonists, combinations → C09DB Angiotensin II antagonists and calcium channel blockers |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 363091112, 363161112, 363301112 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 180M2011 |
| NG | Registered Drug Product Database | B4-2687, B4-2688, B4-2689, B4-2690 |
| TN | Direction de la Pharmacie et du Médicament | 9263261, 9263262, 9263263 |
| ZA | Health Products Regulatory Authority | 46/7.1.3/0542, 46/7.1.3/0543, 46/7.1.3/0544, 46/7.1.3/0545 |
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