SmPC - Pregabalin Accord 75 mg Hard Capsules: Change history
View Summary of Product Characteristics (SmPC - Pregabalin Accord 75 mg Hard Capsules)
Last updated on this site: 16 Feb 2026
Description of update: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC, sections 1, 2, 3, 4 of the leaflet and section 7 of the labeling text to implement the wording recommended by MHRA during the Safety Review for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
Date of approval: 09/02/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
Last updated on this site: 16 Feb 2026
Description of update: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC, sections 1, 2, 3, 4 of the leaflet and section 7 of the labeling text to implement the wording recommended by MHRA during the Safety Review for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
Date of approval: 09/02/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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Changes: (Updated: 16 Feb 2026)
Description of update: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC, sections 1, 2, 3, 4 of the leaflet and section 7 of the labeling text to implement the wording recommended by MHRA during the Safety Review for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
Date of approval: 09/02/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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Changes: (Updated: 15 Aug 2024)
To update sections 4.4, 4.6 and 4.8 of the SmPC in line with the information of the reference product Lyrica 25, 50, 75, 100, 150, 200, 225, 300 mg hard capsules. Consequently, the PIL has been updated.
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Changes: (Updated: 03 Jan 2024)
Description of update: To register an update to the ATC Code for the finished product from N03AX16 to N02BF02 following a WHO recommendation. Consequentially, section 5.1 of the SmPC has been updated.
SmPC Sections updated: 5.1 and 10.
No changes to PIL.
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Changes: (Updated: 27 Mar 2023)
Description of update: To update sections 4.4, 4.8, 4.9 and 5.3 of the SmPC in line with reference product, Lyrica hard capsules updated with procedure outcome of EMEA/H/C/WS2168; MAH: Upjohn EESV, Netherlands, EMEA/H/C/WS2261; MAH: Upjohn EESV, Netherlands and EMEA/H/C/WS2293; MAH: Upjohn EESV, Netherlands. Consequently, the PIL has been updated.
SmPC sections updated: 4.4, 4.8, 4.9, 5.3, 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload