SmPC- Bendamustine hydrochloride 25 mg/ml Concentrate for solution for infusion: Change history
View Summary of Product Characteristics (SmPC- Bendamustine hydrochloride 25 mg/ml Concentrate for solution for infusion)
Last updated on this site: 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.
Last updated on this site: 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.
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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.
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Changes: (Updated: 07 Dec 2023)
Description of update: II, B.II.e.5.c - To add the new presentation {Additional pack (fill volume) of 1 ml of same strength (i.e. 25 mg/mL)}.
SmPC Sections updated: 2, 6.5 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload