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: 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/
Last updated on this site: 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: 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