SmPC - Zopiclone 3.75mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Zopiclone 3.75mg Tablets)
Last updated on this site: 23 Jun 2026
Description of update: To update sections 4.4 and 4.9 of the SmPC in line with the reference product Zimovane 7.5mg film-coated tablets PL 04425/0624, MAH: Aventis Pharma Limited T/A Sanofi.
Date of approval: 19/06/2026
SmPC sections updated: 4.4, 4.9 and 10
Last updated on this site: 23 Jun 2026
Description of update: To update sections 4.4 and 4.9 of the SmPC in line with the reference product Zimovane 7.5mg film-coated tablets PL 04425/0624, MAH: Aventis Pharma Limited T/A Sanofi.
Date of approval: 19/06/2026
SmPC sections updated: 4.4, 4.9 and 10
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Changes: (Updated: 23 Jun 2026)
Description of update: To update sections 4.4 and 4.9 of the SmPC in line with the reference product Zimovane 7.5mg film-coated tablets PL 04425/0624, MAH: Aventis Pharma Limited T/A Sanofi.
Date of approval: 19/06/2026
SmPC sections updated: 4.4, 4.9 and 10
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Changes: (Updated: 19 Jun 2026)
IB, Q.II.f.1.b.1 – Extension of the shelf life of the finished product – As packaged for sale, supported by real time data - Extend shelf-life for Zopiclone 3.75mg Tablets, packed in blisters, from 2 years to 3 years. SmPC Section 6.3 is updated
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Changes: (Updated: 20 Jan 2026)
Description of update: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC, label and leaflet in line with MHRA review to improve communication of risks for dependency-forming medicines. Additionally, an error to section 4.2 of the SmPC has been corrected with a consequential update to section 3 of the leaflet and editorial updates have been made to section 4.4 of the SmPC and leaflet as well as QRD updates to the leaflet.
Date of approval: 13/01/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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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.
SmPC Sections updated: 4.3, 4.4, 4.8, 5.1, 5.2 and 10.
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Changes: (Updated: 07 Jun 2023)
Website administration update
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Changes: (Updated: 22 Sep 2022)
Initial upload