This brand name is authorized in Nigeria.
The drug ZOBIX contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
MHM278SD3E - MONTELUKAST
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Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Τhe CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. |
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2
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UNII
W69HSF2416 - LEVOCETIRIZINE HYDROCHLORIDE
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Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A4-101283 | Tablet | Zobix 15 Tablet TAB 10 mg; 5 mg 3 x 10's (in Alu-Alu blister pack) | Film Coated Tablet Yellow colored, round shaped biconvex, film coated tablet, having both sides plain ZOBIX 15 TABLET Montelukast 10 mg & Levocetirizine Hydrochloride 5 mg Tablets "MONTELUKAST SODIUM BP 10MG, LEVOCETIRIZINE HYDROCHLORIDE USP 5MG, MICROCRYSTALLINE CELLULOSE PH 102 BP 165.37MG, MAGNESIUM STEARATE BP 5MG, PURIFIED TALCUM BP 7MG, CROSCARMELLOSE SODIUM BP 10MG, COLLOIDAL SILICON DIOXIDE BP 2MG, QUINOLINE YELLOW IN-HOUSE 6MG, ISOPROPYL ALCOHOL BP 37.68MG, METHYLENE DICHLORIDE BP 90MG." A4-101283 Drugs Imported Product 310 18-09-2024 ZOBIF PHARMACEUTICALS LIMITED, ONAFOWOKAN STREET ISHERI OSHUN LAGOS LAGOS 08057185033 zobifdossier@gmail.com "SHUKRA PHARMACEUTICALS LTD., Plot No. 795, Rakanpur Sola-Santej Road, Ta. Kalol, Dist. Gandhinagar Gujarat, India" | 30/04/2025 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| R03DC53 | R Respiratory system → R03 Drugs for obstructive airway diseases → R03D Other systemic drugs for obstructive airway diseases → R03DC Leukotriene receptor antagonists | |
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 | A4-101283 |
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