SmPC - Levofloxacin 500mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Levofloxacin 500mg Film-coated Tablets)
Last updated on this site: 13 Aug 2024
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)
Last updated on this site: 13 Aug 2024
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)
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Changes: (Updated: 13 Aug 2024)
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)
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Changes: (Updated: 21 Sep 2022)
Initial upload