SmPC - Daptomycin 500mg Powder for solution for injection/infusion: Change history
View Summary of Product Characteristics (SmPC - Daptomycin 500mg Powder for solution for injection/infusion)
Last updated on this site: 30 Jun 2026
Description of update: Adaption of the SmPC in accordance with EMA recommendation concerning MIC information and the heading and the text to be inserted in Section 5.1 of the SmPC (EMA/457563/2023) for Daptomycin.
Date of approval: 22/06/2026
SmPC sections updated: 5.1 and 10
Last updated on this site: 30 Jun 2026
Description of update: Adaption of the SmPC in accordance with EMA recommendation concerning MIC information and the heading and the text to be inserted in Section 5.1 of the SmPC (EMA/457563/2023) for Daptomycin.
Date of approval: 22/06/2026
SmPC sections updated: 5.1 and 10
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Changes: (Updated: 30 Jun 2026)
Description of update: Adaption of the SmPC in accordance with EMA recommendation concerning MIC information and the heading and the text to be inserted in Section 5.1 of the SmPC (EMA/457563/2023) for Daptomycin.
Date of approval: 22/06/2026
SmPC sections updated: 5.1 and 10
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Changes: (Updated: 27 Jul 2023)
The proposed change is:
C.I.2.a) Implementation of change(s) for which no new additional data is required to be submitted by the MAH
- Adaption of the SPC and PIL to the reference product Cubicin (EU/1/05/328); furthermore editorial changes
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Changes: (Updated: 20 Sep 2022)
Initial upload