This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Canada, Cyprus, Ecuador, Estonia, Finland, Germany, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Turkey, UK.
The drug FUCIDIN contains one active pharmaceutical ingredient (API):
1
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UNII
J7P3696BCQ - FUSIDATE SODIUM
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Fusidic acid belongs to a unique group of antibiotics, the fusidanes, which act to inhibit bacterial protein synthesis by blocking the lengthening of factor G. Fusidic acid is active against staphylococcus epidermidis and methicillin resistant staphylococci. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| C4-0386 | Cream | FUCIDIN CREAM CREAM 20 mg 1 X 15G | FUCIDIN CREAM FUCIDIN FUSIDIC ACID 20MG/G CREAM POM CREAM 1 X 15G ANTIBACTERIAL ASSENE-LABOREX LTD, 7C CREEK ROAD, APAPA, LAGOS STATE. LEO LABORATORIES LIMITED DUBLIN 12, IRELAND GMP- SATIS; LR- SATIS; FEES- PAID; NP:NA 16/10/2018 C4-0386 | 30/01/2020 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| FUCIDIN Oral Suspension | 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 | |
|---|---|---|
| D06AX01 | Fusidic acid | D Dermatologicals → D06 Antibiotics and chemotherapeutics for dermatological use → D06A Antibiotics for topical use → D06AX Other antibiotics for topical use |
| D09AA02 | Fusidic acid | D Dermatologicals → D09 Medicated dressings → D09A Medicated dressings → D09AA Medicated dressings with antiinfectives |
| J01XC01 | Fusidic acid | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01X Other antibacterials → J01XC Steroid antibacterials |
| S01AA13 | Fusidic acid | S Sensory organs → S01 Ophthalmologicals → S01A Antiinfectives → S01AA Antibiotics |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10782L, 2312Q |
| CA | Health Products and Food Branch | 00586668, 00586676 |
| DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 01422714, 01422720, 12509743, 12509766, 12509772, 12509789 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 15.929-3-04-06, 15.940-3-04-06 |
| EE | Ravimiamet | 1007727, 1007750, 1131871, 1148194, 1863446 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 055764, 431023, 436410, 573576 |
| GB | Medicines & Healthcare Products Regulatory Agency | 138819, 15537, 15538, 15553, 15554, 36710, 36722, 379095 |
| HK | Department of Health Drug Office | 37407, 37408, 37411 |
| IE | Health Products Regulatory Authority | 26210, 26808, 59315, 59411, 59436, 59854, 60604 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 2688, 4930, 4931 |
| JP | 医薬品医療機器総合機構 | 2634708M1037 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1006096, 1006097, 1061829, 1061830, 1062785, 1062786, 1076814, 1079172, 1079173, 1080044, 1080045, 1081422, 1081423, 1082480, 1086733, 1086937, 1087925, 1088024, 1088454, 1091583 |
| MT | Medicines Authority | MA1313/00102, MA1313/00103 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 118M86, 183M86 |
| NG | Registered Drug Product Database | C4-0386 |
| NL | Z-Index G-Standaard | 12329657 |
| NL | Z-Index G-Standaard, PRK | 16705, 5401, 5428 |
| NZ | Medicines and Medical Devices Safety Authority | 610 |
| PL | Rejestru Produktów Leczniczych | 100075377, 100075383, 100225718, 100226215, 100258066, 100258072, 100260287, 100264658, 100283495, 100286915, 100324573, 100324580, 100326187, 100326193, 100327590, 100357816, 100382665, 100382719, 100386031, 100386048, 100394912, 100401285, 100418558, 100423447, 100423967, 100446514, 100448513, 100456129, 100458648, 100467631 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W59985001, W59986001 |
| SG | Health Sciences Authority | 00722P, 01547P, 04985P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699514090335, 8699514090342, 8699514090359, 8699514352853, 8699514382652, 8699514382867 |
| ZA | Health Products Regulatory Authority | A/20.1/587, Q/20.1.6/0128 |
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