PIL - Oxaliplatin 5mg/ml Concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL - Oxaliplatin 5mg/ml Concentrate for solution for infusion)
Last updated on this site: 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.
PIL sections updated: Introduction, 2, 4 and 6.
Last updated on this site: 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.
PIL sections updated: Introduction, 2, 4 and 6.
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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.
PIL sections updated: Introduction, 2, 4 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload