SmPC - Oxaliplatin 5mg/ml Concentrate for solution for infusion: Change history
View Summary of Product Characteristics (SmPC - Oxaliplatin 5mg/ml Concentrate for solution for infusion)
Last updated on this site: 07 Nov 2024
To update sections 4.4, 4.6, 5.2 and PIL in line with information of reference product (ELOXATINE 5mg/ml, concentrate for solution for infusion; MAH: SANOFI WINTHROP INDUSTRIE, France; DCP procedure number- FR/H/0144/002).
Last updated on this site: 07 Nov 2024
To update sections 4.4, 4.6, 5.2 and PIL in line with information of reference product (ELOXATINE 5mg/ml, concentrate for solution for infusion; MAH: SANOFI WINTHROP INDUSTRIE, France; DCP procedure number- FR/H/0144/002).
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Changes: (Updated: 07 Nov 2024)
To update sections 4.4, 4.6, 5.2 and PIL in line with information of reference product (ELOXATINE 5mg/ml, concentrate for solution for infusion; MAH: SANOFI WINTHROP INDUSTRIE, France; DCP procedure number- FR/H/0144/002).
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Changes: (Updated: 25 Mar 2024)
Description of update: To submit Type IB (C.I.2.a) variation application to update SmPC sections 4.2, 4.3, 4.4, 4.6, 4.8 and 4.9 and leaflet sections 2 and 4 in-line information with the reference product (Eloxatin 5mg/ml concentrate for solution for infusion; EU procedure number- FR/H/0144/002; MAH: Sanofi). Additionally, applicant has update sections 4.1, 4.3 and 5.2 of SmPC with editorial changes.
SmPC Sections updated: 4.2, 4.3, 4.4, 4.6, 4.8, 4.9 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload