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Intended for UK patients and members of the public

Bendamustine Solution

Active Ingredients

Product Documentation

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Bendamustine hydrochloride 25 mg/ml Concentrate for solution for infusion

PL Number:
20075/1397
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • - 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.

  • - 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Bendamustine hydrochloride 2.5 mg/ ml Powder for Concentrate for solution for infusion

PL Number:
20075/0459
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • - 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.

  • - 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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