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PIL- Daptomycin 350, 500mg powder for solution for injection/infusion: Change history

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  • View Patient Information Leaflet (PIL- Daptomycin 350, 500mg powder for solution for injection/infusion)

    Last updated on this site: 18 Nov 2025

    A.5.b. - IA - Administrative changes. Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites). The activities for which the manufacturer/importer is responsible do not include batch release.:
    Change in the name and address of manufacturer from “Pharmavalid Ltd. Microbiological Laboratory (Fab. Budapest) Tátra u. 27/b., - 1136 - Budapest - HU” to “Pharmavalid Kft. (Fab. Budapest) Tátra u. 27/b - Budapest 1136 Budapest HU” as batch control/testing site.

     

    A.7. - IA - Administrative changes. Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier).:
    Delete the manufacturer "Accord Healthcare B.V. (Fab. Utrecht II) Winthontlaan 200 - 3526 KV - Utrecht - NL" as responsible batch release.

     

    A.5.b. - IA - Administrative changes. Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites). The activities for which the manufacturer/importer is responsible do not include batch release.:
    Change in the name and address of manufacturer from “Eurofins Analytical Services Hungary Kft. (Fab. Budapest) Kerulet, Anonymus Utca 6/IV, IV Kerulet - 1045 - Budapest - HU” to “Eurofins BioPharma Product Testing Budapest Kft. (Fab. Budapest) Anonymus Utca 6, Kerulet 1045 Budapest IV HU” as batch control/testing site.

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    • Changes: (Updated: 18 Nov 2025)

      A.5.b. - IA - Administrative changes. Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites). The activities for which the manufacturer/importer is responsible do not include batch release.:
      Change in the name and address of manufacturer from “Pharmavalid Ltd. Microbiological Laboratory (Fab. Budapest) Tátra u. 27/b., - 1136 - Budapest - HU” to “Pharmavalid Kft. (Fab. Budapest) Tátra u. 27/b - Budapest 1136 Budapest HU” as batch control/testing site.

       

      A.7. - IA - Administrative changes. Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier).:
      Delete the manufacturer "Accord Healthcare B.V. (Fab. Utrecht II) Winthontlaan 200 - 3526 KV - Utrecht - NL" as responsible batch release.

       

      A.5.b. - IA - Administrative changes. Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites). The activities for which the manufacturer/importer is responsible do not include batch release.:
      Change in the name and address of manufacturer from “Eurofins Analytical Services Hungary Kft. (Fab. Budapest) Kerulet, Anonymus Utca 6/IV, IV Kerulet - 1045 - Budapest - HU” to “Eurofins BioPharma Product Testing Budapest Kft. (Fab. Budapest) Anonymus Utca 6, Kerulet 1045 Budapest IV HU” as batch control/testing site.

    • Changes: (Updated: 12 Nov 2025)

      1. Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Pharmavalid Ltd.,Microbiological Laboratory Tátra u. 27/b.,1136,Budapest, Hungary to Pharmavalid Kft., Tátra u. 27/b., 1136, Budapest, Hungary. The address remains unchanged. [Impl. Date: 2024-10-14]

      2. Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Eurofins Analytical Services Hungary Kft., 1045 Budapest, Anonymus ut 6. Hungary to Eurofins BioPharma Product Testing Budapest Kft., 1045 Budapest, Anonymus ut 6. Hungary. The address remains unchanged. [Impl. Date: 2025-01-17]

      3. Type IA (A.7) variation application to delete Accord Healthcare B.V. Winthontlaan 200, 3526KV Utrecht Netherlands as a site responsible for batch release of the finished product. [Impl. Date: 2024-12-12]

    • 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

    • Changes: (Updated: 22 Mar 2024)

      New product launch.

      Launch date: 28/02/2024.

       

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