SmPC - Levetiracetam Accord 500mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Levetiracetam Accord 500mg Film-coated Tablets)
Last updated on this site: 03 Jul 2023
Description of update: To update section 4.4 and 4.8 of the SmPC and section 2 and 4 of PIL in-line with the reference product, Keppra 250/500/750/1000 mg film-coated tablets; EU procedure reference number with outcome: EMEA/H/C/WS2339/G; MAH: UCB Pharma SA. Additionally, sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 of SmPC and section 1, 2, 3 and 4 of leaflet is updated with editorial changes in line with reference products.
SmPC sections updated: 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 10.
Last updated on this site: 03 Jul 2023
Description of update: To update section 4.4 and 4.8 of the SmPC and section 2 and 4 of PIL in-line with the reference product, Keppra 250/500/750/1000 mg film-coated tablets; EU procedure reference number with outcome: EMEA/H/C/WS2339/G; MAH: UCB Pharma SA. Additionally, sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 of SmPC and section 1, 2, 3 and 4 of leaflet is updated with editorial changes in line with reference products.
SmPC sections updated: 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 10.
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Changes: (Updated: 03 Jul 2023)
Description of update: To update section 4.4 and 4.8 of the SmPC and section 2 and 4 of PIL in-line with the reference product, Keppra 250/500/750/1000 mg film-coated tablets; EU procedure reference number with outcome: EMEA/H/C/WS2339/G; MAH: UCB Pharma SA. Additionally, sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 of SmPC and section 1, 2, 3 and 4 of leaflet is updated with editorial changes in line with reference products.
SmPC sections updated: 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 10.
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Changes: (Updated: 20 Jan 2023)
Variation updates: To update section 4.2, 4.5, 4.8 and 5.2 of the SmPC and PIL in line with reference product, Keppra 250/500/750/1000 mg film[1]coated tablets updated with outcome procedure EMEA/H/C/WS2067; MAH: UCB Pharma SA, Belgium for Levetiracetam Accord 250/500/750/1000 mg film-coated tablets.
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Changes: (Updated: 21 Sep 2022)
Initial upload