This brand name is authorized in Nigeria.
The drug ROMCIN contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
779619577M - CLOBETASOL PROPIONATE
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Clobetasol propionate, like other topical corticosteroids, has anti-inflammatory, antipruritic, and vasoconstrictive properties. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. |
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2
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UNII
R9400W927I - KETOCONAZOLE
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Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. |
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3
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UNII
057Y626693 - NEOMYCIN SULFATE
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Neomycin is an aminoglycoside antibiotic and acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A4-5535 | Cream | ROMCIN CREAM CREAM 0.25 mg/g; 10 mg/g; 5000 IU/g 1 X 30g | ROMCIN CREAM KETOCONAZOLE, CLOBETASOL, NEOMYCIN SULPHATE Each gram contains ketoconazole 10mg clobestasol propionate 0.24mg Neomycin sulphate 5000 I.U. A4-5535 Drugs Imported Products 1 X 30g Prescription Only Medicine (POM) 19/11/2021 JUSTEEN PHARMACEUTICALS LTD, COKER ROAD ILUPEJU LAGOS LAGOS LAGOS 17747929 justeen2a@yahoo.com ZHEJIANG JINGWEI PHARM CO. LTD, BAILONGDONG CHENGXI CHANGSHAN COUNTRY, ZHEJIANG, CHINA, China | 31/08/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| D07CD01 | Clobetasol and antibiotics | D Dermatologicals → D07 Corticosteroids, dermatological preparations → D07C Corticosteroids, combinations with antibiotics → D07CD Corticosteroids, very potent, combinations with antibiotics |
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 | A4-5535 |
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