PIL - Linezolid 600mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Linezolid 600mg Film-coated Tablets)
Last updated on this site: 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.
Last updated on this site: 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.
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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.
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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.
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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.
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Changes: (Updated: 21 Sep 2022)
Initial upload