PIL - Levetiracetam Accord 100mg/ml Oral Solution: Change history
View Patient Information Leaflet (PIL - Levetiracetam Accord 100mg/ml Oral Solution)
Last updated on this site: 13 May 2024
Description of update: To update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of PIL in-line with the reference product (Keppra 100mg/ml Oral Solution; EU procedure reference number with outcome: EMEA/H/C/WS2339/G; MAH: UCB Pharma SA, Belgium).
PIL sections updated: 2, 4 and 6.
Last updated on this site: 13 May 2024
Description of update: To update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of PIL in-line with the reference product (Keppra 100mg/ml Oral Solution; EU procedure reference number with outcome: EMEA/H/C/WS2339/G; MAH: UCB Pharma SA, Belgium).
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 13 May 2024)
Description of update: To update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of PIL in-line with the reference product (Keppra 100mg/ml Oral Solution; EU procedure reference number with outcome: EMEA/H/C/WS2339/G; MAH: UCB Pharma SA, Belgium).
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 09 May 2023)
Description of update: Quality changes. Finished product. Manufacture. Change to importer, batch release arrangements and quality control testing of the finished product. Replacement or addition of a manufacturer responsible for importation and/or batch release. Not including batch control/testing.:
Addition of manufacturer "Accord Healthcare B.V. (Fab. Utrecht) Winthontlaan 200, Postbus 85183 3508 AD Utrecht NL" as responsible for importation and batch release.
Administrative changes. Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier).:
Delete the manufacturer "Pharmacare Premium Limited (Fab. Birzebbugia) HHF 003, Hal Far Industrial Estate - BBG 3000 - Birzebbugia - MT" as batch control/testing takes place.
PIL sections affected: 2, 3, 4, 6.
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Changes: (Updated: 13 Feb 2023)
Description of update: C.I.2.a. - IB - Safety, efficacy, pharmacovigilance changes. Human and veterinary medicinal products. Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product. Implementation of change(s) for which no new additional data is required to be submitted by the MAH.:We wish to submit Type IB variation (C.I.2.a) application to update the section 4.8 of SmPC and relevant section of PIL information in-line with reference product (Keppra 100 mg/ml oral solution updated with outcome procedure EMEA/H/C/WS2067; MAH: UCB Pharma SA, Belgium) for Levetiracetam Accord 100 mg/ml oral solution.
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Changes: (Updated: 21 Sep 2022)
Initial upload