SmPC - Azacitidine Accord 25 mg/mL powder for suspension for injection (PLGB 20075/1408): Change history
View Summary of Product Characteristics (SmPC - Azacitidine Accord 25 mg/mL powder for suspension for injection (PLGB 20075/1408))
Last updated on this site: 22 Feb 2024
Description of update: To update sections 4.2 and 4.6 of the SmPC in line with the reference product, Vidaza 25 mg/mL powder for suspension for injection updated with procedure outcome of EMEA/H/C/000978/II/0057; MAH: Bristol-Myers Squibb Pharma EEIG, Ireland. Consequently, the Patient Information Leaflet has been updated. Further updates provided at RFI included:
SmPC section 1 - The following title was added: “SUMMARY OF PRODUCT CHARACTERISTICS” in line with QRD template (version 10.3).
PIL section 4 - formatting update to delete a duplicate full stop.
The SmPC and PIL provided at RFI response includes the changes from the following approved variations:
MHRA ref: PLGB 20075/1408-0021- updates to SmPC section 4.8 and PIL section 4.
MHRA ref: PLGB 20075/1408-0003 - Updates to SmPC sections 4.2, 4.4, 4.8, 5.1 and 5.2
MHRA ref: PLGB 20075/1408-0007 - updates to SmPC sections 2, 6.5, 6.6 and PIL
SmPC Sections updated: 1, 4.2, 4.6 and 10.
Last updated on this site: 22 Feb 2024
Description of update: To update sections 4.2 and 4.6 of the SmPC in line with the reference product, Vidaza 25 mg/mL powder for suspension for injection updated with procedure outcome of EMEA/H/C/000978/II/0057; MAH: Bristol-Myers Squibb Pharma EEIG, Ireland. Consequently, the Patient Information Leaflet has been updated. Further updates provided at RFI included:
SmPC section 1 - The following title was added: “SUMMARY OF PRODUCT CHARACTERISTICS” in line with QRD template (version 10.3).
PIL section 4 - formatting update to delete a duplicate full stop.
The SmPC and PIL provided at RFI response includes the changes from the following approved variations:
MHRA ref: PLGB 20075/1408-0021- updates to SmPC section 4.8 and PIL section 4.
MHRA ref: PLGB 20075/1408-0003 - Updates to SmPC sections 4.2, 4.4, 4.8, 5.1 and 5.2
MHRA ref: PLGB 20075/1408-0007 - updates to SmPC sections 2, 6.5, 6.6 and PIL
SmPC Sections updated: 1, 4.2, 4.6 and 10.
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Changes: (Updated: 22 Feb 2024)
Description of update: To update sections 4.2 and 4.6 of the SmPC in line with the reference product, Vidaza 25 mg/mL powder for suspension for injection updated with procedure outcome of EMEA/H/C/000978/II/0057; MAH: Bristol-Myers Squibb Pharma EEIG, Ireland. Consequently, the Patient Information Leaflet has been updated. Further updates provided at RFI included:
SmPC section 1 - The following title was added: “SUMMARY OF PRODUCT CHARACTERISTICS” in line with QRD template (version 10.3).
PIL section 4 - formatting update to delete a duplicate full stop.
The SmPC and PIL provided at RFI response includes the changes from the following approved variations:
MHRA ref: PLGB 20075/1408-0021- updates to SmPC section 4.8 and PIL section 4.
MHRA ref: PLGB 20075/1408-0003 - Updates to SmPC sections 4.2, 4.4, 4.8, 5.1 and 5.2
MHRA ref: PLGB 20075/1408-0007 - updates to SmPC sections 2, 6.5, 6.6 and PIL
SmPC Sections updated: 1, 4.2, 4.6 and 10.
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Changes: (Updated: 02 Jan 2024)
Description of update: To register an update to sections 4.8 of the SmPC and section 4 of the PL to implement the signal recommendations on Azacitidine (injectable formulations).
SmPC Sections updated: 4.8 and 10.
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Changes: (Updated: 09 Nov 2022)
Initial upload