SmPC - Levetiracetam Accord 100mg/ml Oral Solution: Change history

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.