SmPC - Cytarabine Accord 20 mg/ml solution for injection/infusion: Change history
View Summary of Product Characteristics (SmPC - Cytarabine Accord 20 mg/ml solution for injection/infusion)
Last updated on this site: 27 Apr 2026
Description of update: To update section 4.8 of SmPC and section 4 of leaflet to implement the wording agreed by the PRAC following outcome of the PSUR procedure (PSUSA/00000911/202503) for Cytarabine - to add the adverse reactions neutrophilic eccrine hidradenitis and auricular erythema (“Ara-C ears”) with a frequency unknown.
Date of approval: 14/06/2026
SmPC sections updated: 4.8 and 10
Last updated on this site: 27 Apr 2026
Description of update: To update section 4.8 of SmPC and section 4 of leaflet to implement the wording agreed by the PRAC following outcome of the PSUR procedure (PSUSA/00000911/202503) for Cytarabine - to add the adverse reactions neutrophilic eccrine hidradenitis and auricular erythema (“Ara-C ears”) with a frequency unknown.
Date of approval: 14/06/2026
SmPC sections updated: 4.8 and 10
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Changes: (Updated: 27 Apr 2026)
Description of update: To update section 4.8 of SmPC and section 4 of leaflet to implement the wording agreed by the PRAC following outcome of the PSUR procedure (PSUSA/00000911/202503) for Cytarabine - to add the adverse reactions neutrophilic eccrine hidradenitis and auricular erythema (“Ara-C ears”) with a frequency unknown.
Date of approval: 14/06/2026
SmPC sections updated: 4.8 and 10
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Changes: (Updated: 04 Feb 2025)
To register updated sections 4.2, 4.3 ,4.4, 4.5, 4.6 and 4.8 of the SmPC fragments. This is in line with the information of Reference product (Cytarabine 20 mg/ml Solution for Injection or Infusion; National authorisation number: PA0822/200/001; MAH: Pfizer Healthcare Ireland). Consequently, the leaflet is updated.
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Changes: (Updated: 08 Aug 2023)
Renewal approval 02/08/2023
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Changes: (Updated: 21 Oct 2022)
Update
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Changes: (Updated: 20 Sep 2022)
Initial upload