SmPC - Vinorelbine 10mg/ml Concentrate for solution for infusion: Change history
View Summary of Product Characteristics (SmPC - Vinorelbine 10mg/ml Concentrate for solution for infusion)
Last updated on this site: 20 Jun 2023
Description of update: To update section 4.8 of the SmPC in line with the reference product information (NAVELBINE 10 mg/ml, concentraat voor oplossing voor infusie; MAH: PIERRE FABRE MEDICAMENT,FRANKRIJK; MA No.: RVG 18020). Consequently, the Patient Information Leaflet has also been updated.
SmPC sections updated: 4.8, 10.
Last updated on this site: 20 Jun 2023
Description of update: To update section 4.8 of the SmPC in line with the reference product information (NAVELBINE 10 mg/ml, concentraat voor oplossing voor infusie; MAH: PIERRE FABRE MEDICAMENT,FRANKRIJK; MA No.: RVG 18020). Consequently, the Patient Information Leaflet has also been updated.
SmPC sections updated: 4.8, 10.
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Changes: (Updated: 20 Jun 2023)
Description of update: To update section 4.8 of the SmPC in line with the reference product information (NAVELBINE 10 mg/ml, concentraat voor oplossing voor infusie; MAH: PIERRE FABRE MEDICAMENT,FRANKRIJK; MA No.: RVG 18020). Consequently, the Patient Information Leaflet has also been updated.
SmPC sections updated: 4.8, 10.
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Changes: (Updated: 05 May 2023)
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.
SmPC sections updated: 4.8, 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload