SmPC - Pregabalin Accord 200 mg Hard Capsules: Change history
View Summary of Product Characteristics (SmPC - Pregabalin Accord 200 mg Hard Capsules)
Last updated on this site: 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.
Last updated on this site: 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: 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