PIL - Levofloxacin 250mg, 500mg Film-coated Tablets: Change history

Changes in the Summary of Product Characteristics and Package Leaflet in line with the reference product Tavanic. Editorial changes and updates in line with the QRD template.

- Type IB (C.1.2.a) variation application to update section 4.8 of SmPC and section 4 of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; outcome of procedure UK/H/0203/001-003/II/072 MAH: Sanofi-Aventis Deutschland GmbH)

- Type IB (C.1.2.a) variation application to update section 4.4 and 4.8 of SmPC and corresponding section of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; outcome of procedure DE/H/xxxx/WS/594; MAH: Sanofi-Aventis Deutschland GmbH)

- Type IB (C.1.2.a) variation application to update section 4.4, 4.7, 4.8 and 5.1 of SmPC and corresponding sections of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; DCP procedure number: DE/H/5119/001-003/IB/096/G; MAH: Sanofi-Aventis Deutschland GmbH)

- Type IB (C.1.2.a) variation application to update section 4.4 and 4.8 of SmPC and section corresponding sections of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; outcome of procedure DE/H/xxxx/WS/1098: DE/H/5119; MAH: Sanofi-Aventis Deutschland GmbH)