PIL - Cytarabine100mg/ml solution for injection or infusion: Change history
View Patient Information Leaflet (PIL - Cytarabine100mg/ml solution for injection or infusion)
Last updated on this site: 14 Nov 2025
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
Last updated on this site: 14 Nov 2025
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
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Changes: (Updated: 14 Nov 2025)
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
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Changes: (Updated: 20 Sep 2022)
Initial upload