PIL- Daptomycin 350, 500mg powder for solution for injection/infusion: Change history
View Patient Information Leaflet (PIL- Daptomycin 350, 500mg powder for solution for injection/infusion)
Last updated on this site: 13 Oct 2025
Description of update: To update SmPC sections 4.2, 4.4, 5.2 in-line with information of reference product (Cubicin 350 mg & 500 mg powder for solution for injection or infusion; EU procedure number: EMEA/H/C/000637; MAH: Merck Sharp & Dohme B.V.) along with updation of susceptibility testing breakpoints in SmPC section 5.1 and the minor editorial changes in line with QRD update in leaflet section 3 and 6.
Date of approval: 06/10/2025
PIL sections updated: 3 and 6
Last updated on this site: 13 Oct 2025
Description of update: To update SmPC sections 4.2, 4.4, 5.2 in-line with information of reference product (Cubicin 350 mg & 500 mg powder for solution for injection or infusion; EU procedure number: EMEA/H/C/000637; MAH: Merck Sharp & Dohme B.V.) along with updation of susceptibility testing breakpoints in SmPC section 5.1 and the minor editorial changes in line with QRD update in leaflet section 3 and 6.
Date of approval: 06/10/2025
PIL sections updated: 3 and 6
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Changes: (Updated: 13 Oct 2025)
Description of update: To update SmPC sections 4.2, 4.4, 5.2 in-line with information of reference product (Cubicin 350 mg & 500 mg powder for solution for injection or infusion; EU procedure number: EMEA/H/C/000637; MAH: Merck Sharp & Dohme B.V.) along with updation of susceptibility testing breakpoints in SmPC section 5.1 and the minor editorial changes in line with QRD update in leaflet section 3 and 6.
Date of approval: 06/10/2025
PIL sections updated: 3 and 6
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Changes: (Updated: 22 Mar 2024)
New product launch.
Launch date: 28/02/2024.