Accord Logo

Intended for UK patients and members of the public

Additional Information

Please note that some products on this page share the same name. Please take extra care to make sure the PL number of your medicine matches the PL number of the medicine you select on this page. The PL number can be found on your medicine bottle or carton. If you are unsure, please contact your pharmacist.

Azacitidine 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

Azacitidine Accord 25 mg/mL powder for suspension for injection

PL Number:
PLGB 20075/1408
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

  • 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.

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

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Azacitidine Accord 25mg/mL powder for suspension for injection

PL Number:
EU/1/19/1413/001-002
MA Holder:
Accord Healthcare S.L.U
Product Classification:
POM
Product Status:
Discontinued

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

For any further assistance, please get in touch.

View product information as a: