Intended for UK patients and members of the public
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.
Report a side effect or a product complaintProduct Documentation
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.
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
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.
Report a side effect or a product complaintFor any further assistance, please get in touch.