PIL- Atomoxetine 10, 18, 25, 40, 60, 80, 100mg Hard Capsules: Change history
View Patient Information Leaflet (PIL- Atomoxetine 10, 18, 25, 40, 60, 80, 100mg Hard Capsules)
Last updated on this site: 10 Dec 2024
Variation to update SmPC sections 4.4, 4.5, 4.8, 4.9 and leaflet sections 2, 3, 4 to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00000262/202311).
Last updated on this site: 10 Dec 2024
Variation to update SmPC sections 4.4, 4.5, 4.8, 4.9 and leaflet sections 2, 3, 4 to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00000262/202311).
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Changes: (Updated: 10 Dec 2024)
Variation to update SmPC sections 4.4, 4.5, 4.8, 4.9 and leaflet sections 2, 3, 4 to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00000262/202311).
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Changes: (Updated: 18 Apr 2024)
Description of update: This notification is submitted to amend the packaging components without the need to amend the SmPC. Changes notified are as follows:
To create additional cartons and foils for the Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg Hard Capsules pack size 28s for the additional machine 921
To create a joint PIL for the additional machine 921 for Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules
PIL sections updated: 6 only.
No updates to SmPC.
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Changes: (Updated: 08 Mar 2024)
Description of update: 'UK Only' added to the outer labelling of the products in accordance with the Windsor Framework requirements. All references to Ireland have also been removed, where the packs were previously shared.
PIL sections updated: 1, 2, 3, 4 & 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload