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Intended for UK patients and members of the public

Cytarabine100mg/ml solution for injection or infusion

Cytarabine100mg/ml solution for injection or infusion

PL Number:
20075/0121
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update: To update sections 4.3, 4.4, 4.5 & 4.8 of the SmPC and sections 2 & 4 of PIL in line with the information of Reference product Cytarabine 100 mg/ml Solution for Injection; National authorisation number: PA0822/200/002; MAH: Pfizer Healthcare Ireland). To update section 4.3 and 4.6 of SmPC and section 2 of PIL information leaflet with the contraception duration for men and women as per the SWP recommendation.

    Date of approval: 01/10/2025

    SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.3 and 10

  • Description of update: To update sections 4.3, 4.4, 4.5 & 4.8 of the SmPC and sections 2 & 4 of PIL in line with the information of Reference product Cytarabine 100 mg/ml Solution for Injection; National authorisation number: PA0822/200/002; MAH: Pfizer Healthcare Ireland). To update section 4.3 and 4.6 of SmPC and section 2 of PIL information leaflet with the contraception duration for men and women as per the SWP recommendation.

    Date of approval: 01/10/2025

    PIL sections updated: 2, 3, 4 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.

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