Accord Logo

Intended for UK patients and members of the public

PIL- Bendamustine hydrochloride 2.5 mg/ ml Powder for Concentrate for solution for infusion: Change history

  • - Type IB (C.1.2.a) To update section 4.8 of SmPC and section 4 of PIL in line with the information of the reference product (Levact; DCP procedure number: DE/H/1250/001; MAH: Astellas Pharma GmbH retrieved from HMA website).

     

    - Type IB (C.1.z) To update section 4.4, 4.6 of SmPC and section 2 of PIL according to SWP recommendations on the duration of contraception for men and women following the end of treatment with a genotoxic drug.

     

    Additionally, sections 4.2, 4.5, 5.1 SmPC and sections 2, 3 and 5 of leaflet have been updated with editorial changes in line with reference product information.

    • Changes: (Updated: 16 Jul 2024)

      - Type IB (C.1.2.a) To update section 4.8 of SmPC and section 4 of PIL in line with the information of the reference product (Levact; DCP procedure number: DE/H/1250/001; MAH: Astellas Pharma GmbH retrieved from HMA website).

       

      - Type IB (C.1.z) To update section 4.4, 4.6 of SmPC and section 2 of PIL according to SWP recommendations on the duration of contraception for men and women following the end of treatment with a genotoxic drug.

       

      Additionally, sections 4.2, 4.5, 5.1 SmPC and sections 2, 3 and 5 of leaflet have been updated with editorial changes in line with reference product information.

    • Changes: (Updated: 22 May 2023)

      Website administration update

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

    View product information as a: