This brand name is authorized in Nigeria.
The drug THEOCLAV 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 |
|---|---|---|---|---|
| B4-6890 | Tablet | THEOCLAV 375 TABLETS TAB 250 mg; 125 mg 2 X 10 | 33 RNW-PP-230069 THEOCLAV 375 TABLETS AMOXICILLIN + POTASSIUM CLAVULANATE Amoxicillin 250mg + Clavulanate Potassium 125mg Excipient q.s B4-6890 Drugs Imported Products 210 Prescription Only Medicine (POM) 1/19/2022 SYNERMED (NIGERIA) LIMITED, ADENIYI JONES IKEJA LAGOS LAGOS 8035873263 synermednigeria@hotmail.com M/S THEON PHARMACEUTICALS LTD, VILLAGE SAINI MAJRA, THE. NALAGARH, DISTT. SOLAN (H.P)-174 101, INDIA, India | 31/10/2023 |
| B4-6892 | Tablet | THEOCLAV 1000 TABLETS TAB 875 mg; 125 mg 1 X 10 | 68 RNW-PP-230544 THEOCLAV 1000 TABLETS AMOXICILLIN + CLAVULANATE POTASSIUM Amoxicillin 875mg + Clavulante potassium 125mg Excipients q.s B4-6892 Drugs Imported Products 110 Prescription Only Medicine (POM) 1/19/2022 SYNERMED (NIGERIA) LIMITED, ADENIYI JONES IKEJA LAGOS LAGOS 8035873263 synermednigeria@hotmail.com M/S THEON PHARMACEUTICALS LTD, VILLAGE SAINI MAJRA, THE. NALAGARH, DISTT. SOLAN (H.P)-174 101, INDIA, India | 06/07/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| 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) |
|---|---|---|
| NG | Registered Drug Product Database | B4-6890, B4-6892 |
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