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PIL - Linezolid 600mg Film-coated Tablets: Change history

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  • View Patient Information Leaflet (PIL - Linezolid 600mg Film-coated Tablets)

    Last updated on this site: 28 Feb 2025

    - Type IB, Category (C.I.2.a): To update SmPC sections 4.4, 4.8, 5.1 and PIL sections 2, 4 in line with information of reference product (Zyvox 600 mg Film-Coated Tablets; IE procedure number: IE/H/0644/001; MAH: Pfizer Healthcare Ireland) along with the minor editorial changes in line with reference product.

    - Type IB, Category (C.I.z): To update SmPC section 5.1 in line with recommendation published by EMA for relocation of MIC data from PI. In addition:

    • The soya excipient information in SmPC section 4.3 and PIL section 2 has been updated in line with Excipient guidelines.

    • Editorial and formatting updates to SmPC sections 4.4, 4.8 and the PIL.

    • The national reporting system text in SmPC section 4.8 and PIL has been updated in line with latest QRD template (version 10.4). The country table has been removed from the PIL.

    PIL sections updated: Heading, Index, 1, 2, 3, 4, 5 and 6.

    View change history

    • Changes: (Updated: 28 Feb 2025)

      - Type IB, Category (C.I.2.a): To update SmPC sections 4.4, 4.8, 5.1 and PIL sections 2, 4 in line with information of reference product (Zyvox 600 mg Film-Coated Tablets; IE procedure number: IE/H/0644/001; MAH: Pfizer Healthcare Ireland) along with the minor editorial changes in line with reference product.

      - Type IB, Category (C.I.z): To update SmPC section 5.1 in line with recommendation published by EMA for relocation of MIC data from PI. In addition:

      • The soya excipient information in SmPC section 4.3 and PIL section 2 has been updated in line with Excipient guidelines.

      • Editorial and formatting updates to SmPC sections 4.4, 4.8 and the PIL.

      • The national reporting system text in SmPC section 4.8 and PIL has been updated in line with latest QRD template (version 10.4). The country table has been removed from the PIL.

      PIL sections updated: Heading, Index, 1, 2, 3, 4, 5 and 6.

    • Changes: (Updated: 27 Apr 2023)

      Description of update: Type IB: C.I.2.a

      Change in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product. a) Implementation of change(s) for which no new additional data are submitted by the MAH. The date of approval is 26 April 2023.

      PIL sections updated: 2, 3, 4, 6.

    • Changes: (Updated: 14 Apr 2023)

      Variation description: A.7; deletion of Accord Healthcare Limited, Ground Floor, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4 HF, United Kingdom as Batch Release site and deletion of Astron Research Limited, 2nd & 3rd floor, Sage House, 319 Pinner Road, Harrow HA1 4HF, Middlesex, UK & Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, UK as Batch testing site for Linezolid 600 mg Film-coated Tablets.

      PIL sections updated: 6.

    • Changes: (Updated: 05 Jan 2023)

      To update the section 4.4 of SPC and section 2, 3, and 4 of PIL in-line with reference product information (Zyvoxid 600 mg, filmomhulde tabletten; MAH: Pfizer bv, Capelle a/d Ijssel, MA Number: RVG 26569) for Linezolid 600 mg Film-coated Tablets.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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