PIL- Bleomycin 15000 IU Powder for solution for injection/ infusion: Change history
View Patient Information Leaflet (PIL- Bleomycin 15000 IU Powder for solution for injection/ infusion)
Last updated on this site: 17 Oct 2025
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.
Last updated on this site: 17 Oct 2025
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.
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Changes: (Updated: 17 Oct 2025)
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.
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Changes: (Updated: 25 Nov 2024)
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/
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Changes: (Updated: 22 Sep 2023)
Description of update: This application is submitted to change the packaging components without the need to change the SmPC. The changes applied for fall into the following category: We wish file article 61 (3) notification to correct the cumulative dose information for medical professionals of PIL.
The applicant has submitted the type II variation (UK-H-6023- 001-II-002) to update the SPC and PIL in line with reference product. However, applicant miss to update the cumulative dose for Squamous cell carcinoma in information for medical professionals in the leaflet. Therefore, applicant is submitting the article 61(3) notification to harmonise the dose for Squamous cell carcinoma in leaflet in-line with approved SPC.
PIL sections updated: 2, 6, section for Healthcare Professionals.
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Changes: (Updated: 24 Aug 2023)
Description of update: Article 61 (3) notification to update cumulative dose information for medical professionals in PIL in-line with approved SmPC.
PIL sections updated: 2, 6.
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Changes: (Updated: 23 Aug 2023)
Description of update: Article 61(3) notification to update cumulative dose information for medical professionals in PIL in-line with approved SPC.
PIL sections updated: 2, 6.
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Changes: (Updated: 23 Jun 2023)
Description of update: The following change(s) has been notified:
Type IAIN variation (C.I.3.a) application to update the SmPC section 4.4 and leaflet section 2 in-line with the agreed wordings of PSUSA procedure outcome (PSUSA//00000422/202203) for Bleomycin 15000 IU Powder for solution for injection/infusion.
PIL sections updated: 2, 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload