SmPC - Carboplatin 10 mg/ml concentrate for solution for infusion: Change history
View Summary of Product Characteristics (SmPC - Carboplatin 10 mg/ml concentrate for solution for infusion)
Last updated on this site: 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.
Last updated on this site: 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: 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.
SmPC sections updated: 4.4, 4.8, 10.
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Changes: (Updated: 09 Nov 2022)
Updated
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Changes: (Updated: 20 Sep 2022)
Initial upload