This brand name is authorized in Nigeria. It is also authorized in Australia, Cyprus, Ecuador, Estonia, Finland, France, Malta, Netherlands, Singapore, South Africa, Tunisia, Turkey.
The drug COVERAM contains a combination of these active pharmaceutical ingredients (APIs):
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UNII
TFT5IM1KGB - PERINDOPRIL ARGININE
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Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide. Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone. Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system). |
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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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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A4-6816 | Tablet | COVERAM 5MG/10MG TAB 10 mg; 5 mg 1 X 30pack | 13 RNW-PP-264057 COVERAM 5MG/10MG PERINDOPRIL ARGININE 5MG / AMLODIPINE 10MG PERINDOPRIL ARGININE 5MG / AMLODIPINE 10MG A4-6816 Drugs Imported Products 130pack Prescription Only Medicine (POM) 5/13/2022 SERVIER PHARMACEUTICALS DEVELOPMENT LIMITED, 18A, OLU HOLLOWAY ROAD, IKOYI LAGOS LAGOS 9087496733 Kelechi.ebirim@servier.com SERVIER (IRELAND) INDUSTRIES LIMITED, GOREY ROAD - ARKLOW -CO. WICKLOW IRELAND, Ireland | 31/10/2023 |
| A4-6817 | Tablet | COVERAM 10MG/10MG TABLETS TAB 10 mg; 10 mg 1 X 30pack | 12 RNW-PP-263457 COVERAM 10MG/10MG TABLETS PERINDOPRIL ARGININE 10MG / AMLODIPINE 10MG PERINDOPRIL ARGININE 10MG / AMLODIPINE 10MG; Lactose monohydrate, Magnesium stearate( E470B), Cellulose microcrystalline (E460), Colloidal anhydrous silica (E551). A4-6817 Drugs Imported Products 130pack Prescription Only Medicine (POM) 5/13/2022 SERVIER PHARMACEUTICALS DEVELOPMENT LIMITED, 18A, OLU HOLLOWAY ROAD, IKOYI LAGOS LAGOS 9087496733 Kelechi.ebirim@servier.com SERVIER (IRELAND) INDUSTRIES LIMITED, GOREY ROAD - ARKLOW -CO. WICKLOW IRELAND, Ireland | 31/10/2023 |
| A4-6818 | Tablet | COVERAM 10MG/5MG TAB 5 mg; 10 mg 1 X 30pack | 116 RNW-PP-264044 COVERAM 10MG/5MG PERINDOPRIL ARGININE 10MG / AMLODIPINE 5MG PERINDOPRIL ARGININE 10MG / AMLODIPINE 5MG A4-6818 Drugs Imported Products 130pack Prescription Only Medicine (POM) 5/13/2022 SERVIER PHARMACEUTICALS DEVELOPMENT LIMITED, 18A, OLU HOLLOWAY ROAD, IKOYI LAGOS LAGOS 9087496733 Kelechi.ebirim@servier.com SERVIER (IRELAND) INDUSTRIES LIMITED, GOREY ROAD - ARKLOW -CO. WICKLOW IRELAND, Ireland | 30/11/2023 |
| A4-6819 | Tablet | COVERAM 5MG/5MG TAB 5 mg; 5 mg 1 X 30pack | 115 RNW-PP-264071 COVERAM 5MG/5MG PERINDOPRIL ARGININE 5MG / AMLODIPINE 5MG PERINDOPRIL ARGININE 5MG / AMLODIPINE 5MG A4-6819 Drugs Imported Products 130pack Prescription Only Medicine (POM) 5/13/2022 SERVIER PHARMACEUTICALS DEVELOPMENT LIMITED, 18A, OLU HOLLOWAY ROAD, IKOYI LAGOS LAGOS 9087496733 Kelechi.ebirim@servier.com SERVIER (IRELAND) INDUSTRIES LIMITED, GOREY ROAD - ARKLOW -CO. WICKLOW IRELAND, Ireland | 30/11/2023 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| COVERAM Tablet | MPI, EU: SmPC | Pharmaceutical Benefits Scheme (AU) | |
| COVERAM Tablet | MPI, EU: SmPC | Medicines Authority (MT) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| C09BB04 | Perindopril and amlodipine | C Cardiovascular system → C09 Agents acting on the renin-angiotensin system → C09B ACE inhibitors, combinations → C09BB ACE inhibitors and calcium channel blockers |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 9346X, 9347Y, 9348B, 9349C |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 29453-11-10, 29455-11-10, 29471-11-10, 29472-11-10 |
| EE | Ravimiamet | 1288616, 1288627, 1288638, 1288649, 1288650, 1288661, 1288672, 1288683, 1288694, 1288706, 1288717, 1288728, 1288739, 1288740, 1288751, 1288762, 1288773, 1288784, 1288795, 1288807, 1288818, 1288829, 1288830, 1288841, 1288852, 1288863, 1288874, 1288885, 1288896, 1288908, 1288919, 1288920, 1288931, 1288942, 1288953, 1288964, 1288975, 1288986, 1288997, 1289000, 1289011, 1289022, 1289044, 1289055, 1289066, 1289077, 1289088, 1289099, 1289101, 1289112, 1289123, 1289134, 1289145, 1289156, 1289167, 1289178, 1766099, 1766101, 1766112, 1766123 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 153352, 153363, 153374, 153385, 153396, 153407, 153418, 153430 |
| FR | Base de données publique des médicaments | 60187348, 60367022, 60473812, 60660655, 60972480, 61515189, 62216243, 64441025, 65401119, 66159149, 66299756, 66473203, 67126052, 67753553, 69056122, 69163754 |
| MT | Medicines Authority | MA066/01501, MA066/01502, MA066/01503, MA066/01504 |
| NG | Registered Drug Product Database | A4-6816, A4-6817, A4-6818, A4-6819 |
| NL | Z-Index G-Standaard, PRK | 123382, 123390, 123404, 123412 |
| SG | Health Sciences Authority | 13826P, 13827P, 13828P, 13829P |
| TN | Direction de la Pharmacie et du Médicament | 6353161, 6353162, 6353163, 6353164 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699552010616, 8699552010623, 8699552010630, 8699552010647, 8699552091059, 8699552091066, 8699552091073 |
| ZA | Health Products Regulatory Authority | 43/7.1.3/0933, 43/7.1.3/0934, 43/7.1.3/0935, 43/7.1.3/0936 |
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