This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Cyprus, Estonia, Finland, France, Germany, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, Tunisia, UK.
The drug DAKTARIN contains one active pharmaceutical ingredient (API):
1
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UNII
VW4H1CYW1K - MICONAZOLE NITRATE
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Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| 04-1589 | Cream | Daktarin Cream CREAM 2% 1 x 15 g (in Aluminum tube) | Topical Cream | 25/09/2024 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| DAKTARIN Oral gel | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| GYNO-DAKTARIN Vaginal cream | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| DAKTARIN Cream | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| A01AB09 | Miconazole | A Alimentary tract and metabolism → A01 Stomatological preparations → A01A Stomatological preparations → A01AB Antiinfectives and antiseptics for local oral treatment |
| D01AC02 | Miconazole | D Dermatologicals → D01 Antifungals for dermatological use → D01A Antifungals for topical use → D01AC Imidazole and triazole derivatives |
| G01AF04 | Miconazole | G Genito urinary system and sex hormones → G01 Gynecological antiinfectives and antiseptics → G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS → G01AF Imidazole derivatives |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 9027D, 9028E, 9029F, 9031H |
| BR | Câmara de Regulação do Mercado de Medicamentos | 514500403165314 |
| DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 01058906, 04289144 |
| EE | Ravimiamet | 1024579, 1828379 |
| ES | Centro de información online de medicamentos de la AEMPS | 50271, 55962 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 482913, 528837 |
| FR | Base de données publique des médicaments | 62555293, 69184289 |
| GB | Medicines & Healthcare Products Regulatory Agency | 138617, 147179, 147183, 31644, 34584, 34588, 34589, 37792, 37795 |
| IE | Health Products Regulatory Authority | 59803, 59811, 77623 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 1359, 5301 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1012382, 1053042, 1061420, 1076720, 1078433, 1084598, 1084980, 1085244, 1085614, 1085846, 1090619 |
| MT | Medicines Authority | MA1471/00101, MA1471/00102, MA1471/00103, PI908/05201B, PI908/05202A |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 396M79, 76970 |
| NG | Registered Drug Product Database | 04-1589 |
| NL | Z-Index G-Standaard | 12112097, 12112143, 12112178, 13608762 |
| NL | Z-Index G-Standaard, PRK | 2461, 4650, 4669, 72400 |
| NZ | Medicines and Medical Devices Safety Authority | 2054, 2057, 2059, 2061, 2062 |
| PL | Rejestru Produktów Leczniczych | 100016877, 100075928, 100082213, 100122102, 100193869, 100194857, 100259479, 100260264, 100263386, 100298025, 100324567, 100324610, 100350033, 100384345, 100396851, 100401380, 100407075, 100427557, 100463627 |
| SG | Health Sciences Authority | 01114P, 01115P, 02028P |
| TN | Direction de la Pharmacie et du Médicament | 8833031 |
| ZA | Health Products Regulatory Authority | L/20.2.2/183 |
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