SmPC- Quetiapine 50 mg film-coated tablets: Change history
View Summary of Product Characteristics (SmPC- Quetiapine 50 mg film-coated tablets)
Last updated on this site: 05 Sep 2024
To update sections 4.4 and 4.5 of the SmPC in line with PRAC Assessment Report on the PSUR(s) - PSUSA/02589/202307 for quetiapine to add a warning and an interaction regarding concomitant administration of quetiapine and other serotonergic agents. Consequently, the PIL has been updated.
View Summary of Product Characteristics (SmPC- Quetiapine 50 mg film-coated tablets)
Last updated on this site: 05 Sep 2024
To update sections 4.4 and 4.5 of the SmPC in line with PRAC Assessment Report on the PSUR(s) - PSUSA/02589/202307 for quetiapine to add a warning and an interaction regarding concomitant administration of quetiapine and other serotonergic agents. Consequently, the PIL has been updated.
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Changes: (Updated: 05 Sep 2024)
To update sections 4.4 and 4.5 of the SmPC in line with PRAC Assessment Report on the PSUR(s) - PSUSA/02589/202307 for quetiapine to add a warning and an interaction regarding concomitant administration of quetiapine and other serotonergic agents. Consequently, the PIL has been updated.
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Changes: (Updated: 27 Mar 2024)
New product launch.
Launch date: 14/03/2024.