PIL - Vinorelbine 10mg/ml Concentrate for solution for infusion: Change history

Removal of the manufacturer "Accord Healthcare B.V. (Fab. Utrecht II) Winthontlaan 200 - 3526 KV - Utrecht - NL" as the responsible for batch release site.

Description of update: Safety, efficacy, pharmacovigilance changes. Human and veterinary medicinal products. Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of human medicinal products intended to implement the outcome of a procedure concerning PSUR or PASS, or the outcome of the assessment done by the competent authority under Articles 45 or 46 of Regulation 1901/2006. Implementation of wording agreed by the competent authority.:

We wish to file Type IAIN variation (C.I.3.a) to update section 4.8 of SmPC and section 4 of the leaflet in-line with the agreed wordings of PSUSA outcome (PSUSA/00003124/202204) for Vinorelbine 10 mg/mL Concentrate for solution for Infusion.

PIL sections updated: 4, 6.