PIL - Topotecan 1mg/ml Concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL - Topotecan 1mg/ml Concentrate for solution for infusion)
Last updated on this site: 19 Sep 2025
Update SmPC section 4.6 and PIL in line with reference product information.
Corrections in UK SPC section 4.8 to align with common.
Typographical updates in PIL to align with QRD, and UK preferred format.
SmPC sections updated 4.6, 4.8 and 10.
Last updated on this site: 19 Sep 2025
Update SmPC section 4.6 and PIL in line with reference product information.
Corrections in UK SPC section 4.8 to align with common.
Typographical updates in PIL to align with QRD, and UK preferred format.
SmPC sections updated 4.6, 4.8 and 10.
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Changes: (Updated: 19 Sep 2025)
Update SmPC section 4.6 and PIL in line with reference product information.
Corrections in UK SPC section 4.8 to align with common.
Typographical updates in PIL to align with QRD, and UK preferred format.
SmPC sections updated 4.6, 4.8 and 10.
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Changes: (Updated: 15 Aug 2024)
Deletion of Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, Netherland as batch release site
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Changes: (Updated: 02 Nov 2023)
Product information added to Accord product website: 04/11/2023.
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Changes: (Updated: 17 May 2023)
Description of update: Type IB variation (C.I.2.a) application to update SmPC and PIL information in-line with the product information of the reference product (Hycamtin 1mg and 4mg powder for concentrate for solution for infusion, EU Procedure number: EU/1/96/027 MAH: Sandoz Pharmaceuticals d.d).
PIL sections updated: Title, 1, 2, 3, 4, 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload