Intended for UK patients and members of the public
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 complaintProduct Documentation
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
PIL sections updated: 2 and 6.
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.
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 complaintFor any further assistance, please get in touch.