SmPC - Gemcitabine 200 mg Powder for Solution for Infusion: Change history
View Summary of Product Characteristics (SmPC - Gemcitabine 200 mg Powder for Solution for Infusion)
Last updated on this site: 22 Oct 2026
Description of update: To update sections 4.4, 4.8 of SmPC and sections 2, 4 of leaflet to implement the signal recommendation on Gemcitabine - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT 20256) adopted on 08-11 June 2026 PRAC meeting.
Date of approval: 15/10/2026
SmPC sections updated: 4.4, 4.8 and 10
Last updated on this site: 22 Oct 2026
Description of update: To update sections 4.4, 4.8 of SmPC and sections 2, 4 of leaflet to implement the signal recommendation on Gemcitabine - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT 20256) adopted on 08-11 June 2026 PRAC meeting.
Date of approval: 15/10/2026
SmPC sections updated: 4.4, 4.8 and 10
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Changes: (Updated: 22 Oct 2026)
Description of update: To update sections 4.4, 4.8 of SmPC and sections 2, 4 of leaflet to implement the signal recommendation on Gemcitabine - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT 20256) adopted on 08-11 June 2026 PRAC meeting.
Date of approval: 15/10/2026
SmPC sections updated: 4.4, 4.8 and 10
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Changes: (Updated: 31 Jan 2024)
Description of update: To implement the outcome of PSUSA/00001519/202301: Update section 4.4 of the SmPC with a general warning regarding SCARs. Update of section 4.8 of the SmPC under SOC Skin and subcutaneous tissue disorders to add the adverse reaction AGEP with a frequency Not known. Consequential PIL updates.
SmPC Sections updated: 4.4, 4.8 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload