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Intended for UK patients and members of the public

Daptomycin 500mg powder for solution for injection/infusion

Daptomycin 500mg powder for solution for injection/infusion

PL Number:
20075/1387
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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

  • 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

    SmPC sections updated: 4.2, 4.4, 5.1, 5.2 and 10

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

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