This brand name is authorized in Nigeria. It is also authorized in Austria, Cyprus, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Tunisia, Turkey.
The drug TAVANIC contains one active pharmaceutical ingredient (API):
1
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UNII
6GNT3Y5LMF - LEVOFLOXACIN
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Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class. As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA – DNA-gyrase complex and topoisomerase IV. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
---|---|---|---|---|
04-3143 | Tablet | Tavanic Tablets TAB 500 mg | Each tablet contains: Levofloxacin Hemihydrate equiv. to Levofloxacin 500 mg | 21/12/2020 |
04-5409 | Solution for infusion | Tavanic 5 mg/mL Solution for Infusion INJ_SOL 500 mg/100 mL | Solution for Infusion Each mL contains: Levofloxacin 5 mg (500 mg/100 mL) | 26/08/2021 |
Below package inserts are available for further reading:
Document | Type | Information Source | |
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TAVANIC Film-coated tablet | MPI, EU: SmPC | Health Products Regulatory Authority (IE) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
---|---|---|
J01MA12 | Levofloxacin | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01M Quinolone antibacterials → J01MA Fluoroquinolones |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 08586241, 08586264, 08586270, 08752627 |
EE | Ravimiamet | 1102723, 1102734, 1102745, 1102756, 1102767, 1102778, 1102789, 1102790, 1102802, 1102813, 1102824, 1102857, 1102868, 1141669, 1144583, 1144594, 1144606, 1295681, 1295759, 1736636 |
ES | Centro de información online de medicamentos de la AEMPS | 62065 |
FI | Lääkealan turvallisuus- ja kehittämiskeskus | 076950, 375259, 510564 |
FR | Base de données publique des médicaments | 64784789, 69091027 |
IE | Health Products Regulatory Authority | 56911, 56938, 56965 |
IL | מִשְׂרַד הַבְּרִיאוּת | 4191 |
IT | Agenzia del Farmaco | 033634015, 033634039 |
LT | Valstybinė vaistų kontrolės tarnyba | 1009238, 1009239, 1009240, 1009242, 1009243, 1009244, 1009245, 1009246, 1009247, 1068231, 1068232, 1068233, 1068234, 1068235, 1068236, 1068237, 1068238, 1068239, 1068240, 1068241 |
MT | Medicines Authority | MA1359/03801, PI908/07801A |
MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 391M97, 392M97 |
NG | Registered Drug Product Database | 04-3143, 04-5409 |
NL | Z-Index G-Standaard, PRK | 97500 |
PL | Rejestru Produktów Leczniczych | 100101867 |
RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W55699001, W55699002, W55699003, W55699004, W55700001, W55700002, W55700003, W55701001, W55702001 |
TN | Direction de la Pharmacie et du Médicament | 5363041H, 9263141, 9263142 |
TR | İlaç ve Tıbbi Cihaz Kurumu | 8699809097667, 8699809690233 |
ZA | Health Products Regulatory Authority | 32/20.1.1/0123, 32/20.1.1/0124, 32/20.1.1/0125, 34/20.1.1/0002, 43/20.1.1/0947, 43/20.1.1/0948 |
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