SmPC - Oxybutynin hydrochloride XL 5mg Prolonged release Tablets: Change history
View Summary of Product Characteristics (SmPC - Oxybutynin hydrochloride XL 5mg Prolonged release Tablets)
Last updated on this site: 07 Nov 2023
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 of the SmPC and the PIL following reference product comparison with Ditropan tablets 5mg, PL 45043/0036 (MAH: Neon Healthcare Ltd., dated 14/06/2022). Additionally, to update ATC naming in section 5.1 of the SmPC.
SmPC sections updated: 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1 and 10.
Last updated on this site: 07 Nov 2023
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 of the SmPC and the PIL following reference product comparison with Ditropan tablets 5mg, PL 45043/0036 (MAH: Neon Healthcare Ltd., dated 14/06/2022). Additionally, to update ATC naming in section 5.1 of the SmPC.
SmPC sections updated: 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1 and 10.
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Changes: (Updated: 07 Nov 2023)
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 of the SmPC and the PIL following reference product comparison with Ditropan tablets 5mg, PL 45043/0036 (MAH: Neon Healthcare Ltd., dated 14/06/2022). Additionally, to update ATC naming in section 5.1 of the SmPC.
SmPC sections updated: 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1 and 10.
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Changes: (Updated: 14 Aug 2023)
Description of update: To update section 4.8 of the SmPC and section 4 of the PIL for Oxybutynin hydrochloride XL 5mg and 10 mg prolonged release tablets in line with the PRAC recommendations (PSUSA/00002253/202207) for ADR palpitation.
SmPC sections updated: 4.8, 10.
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Changes: (Updated: 03 Apr 2023)
To update sections 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Lyrinel XL 5 mg prolonged release tablet (PL 00242/0385; MAH: Janssen-Cilag Ltd: dated 08/04/2020). Consequently, the PIL has been updated. In addition, section 4.4 of the SmPC and PIL has been updated to align the excipient information for lactose and sodium with the latest EC Excipient guidelines (version 10.2).
SmPC sections updated – 4.4, 4.8, 5.1, 5.2 and 10
PIL sections updated – Heading, 1, 2, 3, 4 and 6
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Changes: (Updated: 21 Sep 2022)
Initial upload