This brand name is authorized in Nigeria. It is also authorized in Ecuador, Hong Kong SAR China, Ireland, Malta, Poland, South Africa.
The drug CO-AMOXICLAV 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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B4-2496 | Tablet | NEIMETH'S CO AMOXICLAV 625MG TABLET TAB 500 mg; 125 mg 2 X 7 | NEIMETH'S CO AMOXICLAV 625MG TABLET NEIMETH AMOXICILLIN TRIHYDRATE BP EQ. TO AMOXICILLIN 500MG, DILUTED POTASSIUM CLAVULANATE BP 125MG POM TABLETS 2 X 7 ANTIBIOTIC NEIMETH INTERNATIONAL PHARMACEUTICALS PLC 1, HENRY CARR STREET, IKEJA LAGOS MEDOPHARM PVT LTD 50, KAYARAMBEDU VILLAGE, GUDUVANCHERY- 603 202, INDIA GMP- SATIS; LR- SATIS; FEES- PAID; NP: NA 03/04/2017 R R R B4-2496 | 30/01/2020 |
B4-5809 | Powder for injection | Co-Amoxiclav Injection INJ_PWD 1000 mg; 200 mg 1.2 g x 1's (in vial) + 2 x 10 mL SWFI (in ampoules) | Powder for Solution for Injection in vial plus two ampoules of 10 mL sterile water for injection as diluent | 28/02/2024 |
C4-0272 | Tablet | FHL Co-Amoxiclav 1 G Tablet TAB 875 mg; 125 mg | Each tablet contains: Amoxicillin Trihydrate BP equiv. to Amoxicillin 875 mg, Diluted Potassium Clavulanate BP equiv. to Clavulanic Acid 125 mg | 20/12/2019 |
C4-0273 | Tablet | FHL Co-Amoxiclav 625 mg Tablet TAB 500 mg; 125 mg | Each tablet contains: Amoxicillin Trihydrate BP equiv. to Amoxicillin 500 mg, Diluted Potassium Clavulanate BP equiv. to Clavulanic Acid 125 mg | 20/12/2019 |
C4-1445 | Powder for suspension | Co-Amoxiclav Oral Suspension PWD_F_SOL 200 mg/5 mL; 28.5 mg/5 mL | Powder for Oral Suspension | 21/12/2020 |
C4-1446 | Tablet | Co-Amoxiclav 1000 mg Tablets TAB 875 mg; 125 mg | 21/12/2020 | |
C4-2029 | Powder for injection | Co-Amoxiclav Injection INJ_PWD 1000 mg; 200 mg 1.2 g x 1's (in plain glass vial) + 2 x 10 mL SWFI (in ampoules) | Powder for Solution for Injection | 22/10/2022 |
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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EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 7428-MEE-0822 |
HK | Department of Health Drug Office | 49813, 50392 |
IE | Health Products Regulatory Authority | 13107, 15610, 15672, 17925, 17953, 30109, 90132, 90258 |
MT | Medicines Authority | AA565/07902, AA565/07903, AA565/07904, AA807/01201, AA965/00801, AA965/00802, MA1220/00201, MA1220/00202, MA1220/00203, MA807/04101 |
NG | Registered Drug Product Database | B4-2496, B4-5809, C4-027, C4-0272, C4-0273, C4-1445, C4-1446, C4-2029 |
PL | Rejestru Produktów Leczniczych | 100219244, 100219267 |
ZA | Health Products Regulatory Authority | 52/20.1.2/0776, 53/20.1.2/0464, 53/20.1.2/0465 |
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