TAVANIC Film-coated tablet Ref.[50855] Active ingredients: Levofloxacin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Tavanic 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Score line pale yellowish-white to reddish-white film-coated tablets.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each film-coated tablet of Tavanic 500 mg contains 500 mg of levofloxacin as levofloxacin hemihydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levofloxacin

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.

List of Excipients

Tavanic 500 mg film-coated tablets contain the following excipients for a weight of 630 mg:

Tablet core:

Crospovidone
Hypromellose
Microcrystalline cellulose
Sodium stearyl fumarate

Tablet coating:

Hypromellose
Titanium dioxide E171
Talc
Macrogol
Yellow ferric oxide E172
Red ferric oxide E172

Pack sizes and marketing

PVC/ Aluminium blisters containing film-coated tablets.

Pack sizes for 500 mg tablets: 1, 5, 7, 10, 14, 50, 200 and 500 as commercially available.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/077/003

Date of first authorisation: 9th January 1998
Date of last renewal: 31st July 2012

Drugs

Drug Countries
TAVANIC Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Nigeria, Netherlands, Poland, Romania, Tunisia, Turkey, South Africa

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