This brand name is authorized in Nigeria. It is also authorized in Brazil, Canada, Italy, Mexico.
The drug CLAVULIN contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
804826J2HU - AMOXICILLIN
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Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. |
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2
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UNII
Q42OMW3AT8 - CLAVULANATE POTASSIUM
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Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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A4-2848 | Tablet | Clavulin 1G Tablets TAB 875 mg; 125 mg | Film-coated tablet. A white to off-white capsule-shaped film-coated tablet, debossed with ‘AC’ on both sides and a score line on one side | 10/11/2020 |
A4-3022 | Powder for suspension | Clavulin Powder for Oral Suspension PWD_F_SOL 200 mg/5 mL; 28.5 mg/5 mL | Powder for Oral Suspension. A white to off-white dry powder for reconstitution in water to form an off-white mixed fruit flavoured suspension | 28/05/2021 |
A4-3477 | Tablet | Clavulin 625 mg Tablets TAB 500 mg; 125 mg | Film-coated tablet. A white to off-white oval-shaped film-coated tablet, debossed with ‘AC’ and a score line on one side and plain on the other side | 28/05/2021 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
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J01CR02 | Amoxicillin and enzyme inhibitor | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01C Beta-lactam antibacterials, penicillins → J01CR Combinations of penicillins, incl. beta-lactamase inhibitors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
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BR | Câmara de Regulação do Mercado de Medicamentos | 510602005131313, 510602006138311, 510602008130318, 510602009110310, 510602010119318, 510602101130411, 510602102137411, 510602104113410, 510602105111411, 510602201151410, 510602203154417, 510612060048003, 510619040060703, 510619040060803, 510619040060903, 510619040061003 |
CA | Health Products and Food Branch | 01916858, 01916874, 01916882, 02238829, 02238830, 02238831 |
IT | Agenzia del Farmaco | 026138139, 026138192, 026138204, 026138216, 026138228 |
MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 065M2006, 066M98, 215M98, 294M90 |
NG | Registered Drug Product Database | A4-2848, A4-3022, A4-3477 |
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