This brand name is authorized in Nigeria.
The drug BETASOL PLUS 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 |
|---|---|---|---|---|
| B4-9264 | Cream | BETASOL PLUS CREAM CREAM 0.25mg; 10mg; 5000IU 1X30G,1X15G | 43 RNW-PP-339620 BETASOL PLUS CREAM CLOBETASOL PROPIONATE, KETOCONAZOLE, NEOMYCIN SULPHATE Clobetasol Propionate USP 0.25mg, Ketoconazole USP 10mg, Neomycin Sulfate BP 5000IU (EXCIPIENTS: Cetomacrogol 1000 BP, Cetostearyl Alcohol BP, Methyl Hydroxy Benzoate BP, Propyl Hydroxy Benzoate BP, White Soft Paraffin BP (White Petroleum Jelly), Parachloro Meta Cresol (Chlorocresol) BP, Propylene Glycol BP, Anhydrous Sodium Sulphite BP, Sodium Dihydrogen Phosphate Dihydrate BP, Carrot Fragrance 120314 IH, Purified Water (q.s.) BP) B4-9264 Drugs Imported Products 1X30G,1X15G Prescription Only Medicine (POM) 7/5/2023 SHALINA HEALTHCARE NIGERIA LIMITED, 19 Fatai Atere Way, Matori, Mushin Lagos 18183973 theophilus.adimoha@shalina.com Shalina Laboratories Pvt Ltd. , Plot No E-2 & E-3, MIDC Jejuri, Tal Purandar, Pune 412303 Maharashtra State, India, India | 28/02/2024 |
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 | B4-9264 |
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