PIL - Zopiclone 3.75mg, 7.5mg Tablets: Change history
View Patient Information Leaflet (PIL - Zopiclone 3.75mg, 7.5mg Tablets)
Last updated on this site: 08 Apr 2024
Description of update: To update sections 4.3, 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Zimovane LS 3.75 mg, 7.5mg film-coated tablets, PL 04425/0625, 0624 MAH: Aventis Pharma Limited (Sanofi). Consequently, the leaflet has been updated. Additional updates have been made to the SmPC and PIL to correct QRD wording, in line with the QRD template (Version 10.3), spelling, punctuation and grammar.
PIL sections updated: Heading, 2, 4, 5 and 6.
Last updated on this site: 08 Apr 2024
Description of update: To update sections 4.3, 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Zimovane LS 3.75 mg, 7.5mg film-coated tablets, PL 04425/0625, 0624 MAH: Aventis Pharma Limited (Sanofi). Consequently, the leaflet has been updated. Additional updates have been made to the SmPC and PIL to correct QRD wording, in line with the QRD template (Version 10.3), spelling, punctuation and grammar.
PIL sections updated: Heading, 2, 4, 5 and 6.
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Changes: (Updated: 08 Apr 2024)
Description of update: To update sections 4.3, 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Zimovane LS 3.75 mg, 7.5mg film-coated tablets, PL 04425/0625, 0624 MAH: Aventis Pharma Limited (Sanofi). Consequently, the leaflet has been updated. Additional updates have been made to the SmPC and PIL to correct QRD wording, in line with the QRD template (Version 10.3), spelling, punctuation and grammar.
PIL sections updated: Heading, 2, 4, 5 and 6.
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Changes: (Updated: 03 Feb 2023)
Variation Description: To register a change in the address of the manufacturer responsible for the manufacture, batch release, packaging and batch control/testing of the finished product Synthon Hispania S.L. from C/ Castelló, 1-Poligono Las Salinas, 08830 Sant Boi De Llobraegat, Barcelona, Spain to c/Castelló 1, 08830 Sant Boi De Llobregat, Barcelona, Spain. The manufacturing operations and site remain the same. Consequentially, the PIL has been updated.
NOTE: PIL Section 6 has been updated to remove Synthon from listed Manufacturers, as this is not an active batch release site.
Additional editorial changes applied to the PIL:
-Section 2: ‘has’ changed to ‘have’ and ‘applies’ changed to ‘apply’
-Section 4: ‘lasts’ changed to ‘last’
No changes to SmPC
PIL section(s) updated – 2, 4 and 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload