This brand name is authorized in Nigeria.
The drug ROTAMAX contains one active pharmaceutical ingredient (API):
1
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UNII
5FD1131I7S - AZITHROMYCIN DIHYDRATE
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Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis by means of binding to the ribosomal 50S sub-unit and inhibition of peptide translocation. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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A4-100607 | Suspension | ROTAMAX SUSPENSION SUSP 200 mg/5 mL 15ML | 135 NF-PP-338058 ROTAMAX SUSPENSION Azithromycin For Oral Suspension USP 200mg/5ml AZITHROMYCIN FOR ORAL SUSPENSION USP 200MG, EXIPIENTS Q.S A4-100607 Drugs Imported Products 15ML POM 2 6/26/2023 ROTAMEDICS PHARMACY LIMITED, RESERVATION ROAD G.R.A ILORIN ILORIN KWARA 7055888798 rotamedics@gmail.com M/S RELAX BIOTECH.PVT.LTD, 862/1 G.I.D.C., MAKARPURA BARODA-390010 INDIA, India | 30/11/2023 |
A4-100822 | Tablet | ROTAMAX AZITHROMYCIN 250MG TABLETS TAB 250 mg 1 X 6 | 54 NF-PP-378578 ROTAMAX AZITHROMYCIN 250MG TABLETS AZITHROMYCIN 250MG AZITHROMYCIN DIHYDRATE 263MG, PRE GELATINIZED STARCH 16MG, MAIZE STARCH(F/P) 15MG, POVIDONE K-30% 8MG, PURIFIED WATER QS, COLLOIDAL SILICON DIOXIDE 1MG, MAGNESIUM STEARATE 3MG, KYRON T-314 6MG, ISOPROPYL ALCOHOL QS, READY MIX OF IRON OXIDE YELLOW 19MG, METHYLENE CHLORIDE QS A4-100822 Drugs Imported Products 250MG Prescription Only Medicine (POM) ROTAMEDICS PHARMACY LIMITED, RESERVATION ROAD G.R.A ILORIN ILORIN KWARA 7055888798 rotamedics@gmail.com M/s. RELAX BIOTECH PVT LTD, 862/1, G.I.D.C., MAKARPURA, City: VADODARA 391010, Dist.: VADODARA GUJARAT STATE, INDIA., India | 30/04/2024 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
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J01FA10 | Azithromycin | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01F Macrolides, lincosamides and streptogramins → J01FA Macrolides |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
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NG | Registered Drug Product Database | A4-100607, A4-100822 |
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