PIL - Doxorubicin Accord pegylated liposomal 2mg/ml Concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL - Doxorubicin Accord pegylated liposomal 2mg/ml Concentrate for solution for infusion)
Last updated on this site: 06 Dec 2023
Description of update: Update to sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of leaflet information in-line with reference product following the PSUSA outcome EMEA/H/C/PSUSA/00001172/202211). Updated further to include section Side Effects: Frequency not known.
PIL sections updated: 2, 4 and 6.
Last updated on this site: 06 Dec 2023
Description of update: Update to sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of leaflet information in-line with reference product following the PSUSA outcome EMEA/H/C/PSUSA/00001172/202211). Updated further to include section Side Effects: Frequency not known.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 06 Dec 2023)
Description of update: Update to sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of leaflet information in-line with reference product following the PSUSA outcome EMEA/H/C/PSUSA/00001172/202211). Updated further to include section Side Effects: Frequency not known.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 26 Oct 2023)
Description of update: Update to sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of leaflet information in-line with reference product following the PSUSA outcome EMEA/H/C/PSUSA/00001172/202211).
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 29 Jun 2023)
Description of update: To update the sections 4.2, 4.6, 4.7, 4.8 of SmPC and PIL in line with reference product (Caelyx pegylated liposomal 2mg/ml concentrate for solution for infusion updated with outcome of procedure EMEA/H/C/000089, MAH: Baxter Holding B.V., Netherlands) Zolsketil Pegylated Liposomal 2 mg/ml concentrate for dispersion for infusion.
PIL sections updated: 1, 2, 6.
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Changes: (Updated: 27 Feb 2023)
Description of update: To change the product name from ‘Doxorubicin Pegylated Liposomal 2 mg/ml Concentrate for Solution for Infusion’ to ‘Doxorubicin Accord Pegylated Liposomal 2 mg/ml Concentrate for Solution for Infusion’.
Consequentially sections 1, 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 6.4, 6.5, 6.6, 7 of the SmPC, the label and package leaflet, as well as the mock-ups have been updated.
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Changes: (Updated: 27 Feb 2023)
Description of update: To change the product name from ‘Doxorubicin Pegylated Liposomal 2 mg/ml Concentrate for Solution for Infusion’ to ‘Doxorubicin Accord Pegylated Liposomal 2 mg/ml Concentrate for Solution for Infusion’.
Consequentially sections 1, 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 6.4, 6.5, 6.6, 7 of the SmPC, the label and package leaflet, as well as the mock-ups have been updated.
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Changes: (Updated: 20 Sep 2022)
Initial upload