PIL - Carboplatin 10 mg/ml concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL - Carboplatin 10 mg/ml concentrate for solution for infusion)
Last updated on this site: 25 Sep 2024
To register updates to sections 4.1, 4.2, 4.6, 4.8, 5.1, 5.3, 6.5 and 6.6 of the SmPC, along with sections 1, 2 and 6 of the PIL and labelling in line with commitment provided to updated PI documents as per agency comments during RUP (SE/H/1908/001/E/001, approved on 13.02.2023). SmPC section 4.6 and PIL section 2 were updated with amendments to the duration times of contraception use, in line with SWP recommendation. Editorial and QRD updates have also been made to the cartons and vial labels.
Last updated on this site: 25 Sep 2024
To register updates to sections 4.1, 4.2, 4.6, 4.8, 5.1, 5.3, 6.5 and 6.6 of the SmPC, along with sections 1, 2 and 6 of the PIL and labelling in line with commitment provided to updated PI documents as per agency comments during RUP (SE/H/1908/001/E/001, approved on 13.02.2023). SmPC section 4.6 and PIL section 2 were updated with amendments to the duration times of contraception use, in line with SWP recommendation. Editorial and QRD updates have also been made to the cartons and vial labels.
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Changes: (Updated: 25 Sep 2024)
To register updates to sections 4.1, 4.2, 4.6, 4.8, 5.1, 5.3, 6.5 and 6.6 of the SmPC, along with sections 1, 2 and 6 of the PIL and labelling in line with commitment provided to updated PI documents as per agency comments during RUP (SE/H/1908/001/E/001, approved on 13.02.2023). SmPC section 4.6 and PIL section 2 were updated with amendments to the duration times of contraception use, in line with SWP recommendation. Editorial and QRD updates have also been made to the cartons and vial labels.
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Changes: (Updated: 14 Aug 2024)
To update sections 4.3, 4.4, 4.6, 4.8, 5.1 of the SmPC and
sections 2, 4 of the PIL in line with the reference product Carboplatin Hospira 10 mg/ml Onco-Tain, concentrate for solution for infusion 10 mg/ml; MAH: Pfizer eg; National authorisation number: RVG 23321.
Additionally, the typographical error in ATC code in sections 5.1 of the SmPC has been corrected. SmPC section 4.8 ‘Reporting of SARs’ subsection has also been updated in line with QRD. Editorial updates have been made to the PIL.
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Changes: (Updated: 15 Jun 2023)
Description of update: Variation type IB no: C.I.3.z To update the SmPC and PIL in line with wording of PSUSA/00000559/202201.
PIL sections updated: 4, 6.
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Changes: (Updated: 09 Nov 2022)
Initial upload