PIL - Topotecan 1mg/ml Concentrate for solution for infusion: Change history

Last updated on this site: 15 Aug 2024

Deletion of Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, Netherland as batch release site

Changes: (Updated: 15 Aug 2024)

Deletion of Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, Netherland as batch release site
Changes: (Updated: 02 Nov 2023)

Product information added to Accord product website: 04/11/2023.
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.
Changes: (Updated: 22 Sep 2022)

Initial upload

Changes: (Updated: 15 Aug 2024)