This brand name is authorized in Nigeria.
The drug ROTAFLU contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
7AJO3BO7QN - LORATADINE
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Loratadine is a tricyclic antihistamine with selective, peripheral H1-receptor activity. Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage. |
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2
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UNII
6V9V2RYJ8N - PSEUDOEPHEDRINE HYDROCHLORIDE
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Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A4-100697 | Tablet | ROTAFLU TABLET TAB 5mg; 120mg 1 X 10 | 76 NF-PP-82072 ROTAFLU TABLET LORATADINE 5mg & PSESUDOEPHEDRINE HCL 120mg TABLET EACH SRT TABLET CONTAINS: (12 hours) LORATADINE USP 5mg, PSEUDOEPHEDRINE HCL 120mg, Excipients Q.S. Drugs Imported Products 1 X 10 TAB Over The Counter (OTC) 4/3/2019 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 | 31/01/2024 |
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 | A4-100697 |
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