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Intended for UK patients and members of the public

Bleomycin Powder

Active Ingredients

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

Bleomycin 15000 IU Powder for solution for injection/ infusion

PL Number:
20075/0440
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Type IA A.5. b: The activities for which the manufacturer/importer is responsible do not include batch release - variation to change the name of the site responsible for batch control/testing of the finished product from Eurofins Analytical Services Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary to Eurofins BioPharma Product Testing Budapest Kft., Anonymus u. 6., Budapest, 1045, Hungary. The address remains unchanged.

    Type IA A.5. b: The activities for which the manufacturer/importer is responsible do not include batch release - variation to change the name of the site responsible for batch control/testing of the finished product from Lab Analysis S.r.l. Via Europa 5, Casanova Lonati (Pavia), 27041, Italy to Labanalysis Life Science S.r.l., Via Europa 5, Casanova Lonati (Pavia), 27041, Italy. The address remains unchanged.

    Type IA A.7: Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)* - variation to delete Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherland as a site responsible for Batch release.

  • Type IB: B.II.f.1.b.3 - addition of shelf-life of the finished product after dilution/reconstitution, for 10 days when stored at 2 °C to 8 °C and for 48 hours at normal room temperature for Bleomycin 15000 IU Powder for solution for injection/

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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