SmPC - Atrolak XL 50mg Prolonged-release Tablets: Change history
View Summary of Product Characteristics (SmPC - Atrolak XL 50mg Prolonged-release Tablets)
Last updated on this site: 12 Aug 2024
Update SmPC sections 4.1(50, 150 mg), 4.4, 4.8 and leaflet sections 2, 4 to align with information of the reference product (Seroquel XR). Additional update to SPC sections 6.1 for 50, 150 mg excipient names, and consequential update in 150 mg PIL.
To update SmPC sections 4.4 and 4.5 and leaflet section 2 to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (EMEA/H/C/PSUSA/00002589/202307).
Last updated on this site: 12 Aug 2024
Update SmPC sections 4.1(50, 150 mg), 4.4, 4.8 and leaflet sections 2, 4 to align with information of the reference product (Seroquel XR). Additional update to SPC sections 6.1 for 50, 150 mg excipient names, and consequential update in 150 mg PIL.
To update SmPC sections 4.4 and 4.5 and leaflet section 2 to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (EMEA/H/C/PSUSA/00002589/202307).
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Changes: (Updated: 12 Aug 2024)
Update SmPC sections 4.1(50, 150 mg), 4.4, 4.8 and leaflet sections 2, 4 to align with information of the reference product (Seroquel XR). Additional update to SPC sections 6.1 for 50, 150 mg excipient names, and consequential update in 150 mg PIL.
To update SmPC sections 4.4 and 4.5 and leaflet section 2 to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (EMEA/H/C/PSUSA/00002589/202307).
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Changes: (Updated: 23 Dec 2022)
Addition of 'Confusional state' to SmPC section 4.8
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Changes: (Updated: 21 Sep 2022)
Initial upload