SmPC - Zubsolv 8.6/2.1mg Sublingual Tablets: Change history
View Summary of Product Characteristics (SmPC - Zubsolv 8.6/2.1mg Sublingual Tablets)
Last updated on this site: 07 Nov 2024
To update sections 4.5 and 4.8 of the SmPC to add interactions with gabapentinoids and to add the adverse reaction dental caries with a frequency not known in line with PSUSA/00002113/202309. Consequently, the PIL has been updated.
Last updated on this site: 07 Nov 2024
To update sections 4.5 and 4.8 of the SmPC to add interactions with gabapentinoids and to add the adverse reaction dental caries with a frequency not known in line with PSUSA/00002113/202309. Consequently, the PIL has been updated.
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Changes: (Updated: 07 Nov 2024)
To update sections 4.5 and 4.8 of the SmPC to add interactions with gabapentinoids and to add the adverse reaction dental caries with a frequency not known in line with PSUSA/00002113/202309. Consequently, the PIL has been updated.
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Changes: (Updated: 27 Apr 2023)
MA holder: Accord Healthcare Limited
Renewal approval date – 22/03/2023
(Renewal approval received date – 18/04/2023)
Renewal submitted date – 04/02/2022
This product is marketed in the UK
An Unlimited MA has been granted, 4 yearly PSURs will be submitted.
SmPC sections updated – 3, 4.1, 4.2, 4.4, 4.5, 4.8, 5.2, 5.3, 6.1, 6.4, 6.5, 9 and 10
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Changes: (Updated: 16 Mar 2023)
Variation Description: To update sections 4.4, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to bring in line with the reference product (Suboxone 2 mg/0.5 mg sublingual tablets. Consequently, the PIL has been updated.
Minor editorial changes have also been made to the PIL.
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Changes: (Updated: 22 Sep 2022)
Initial upload