SmPC- Naproxen 500mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Naproxen 500mg Tablets)
Last updated on this site: 15 Aug 2024
To update sections 4.4 and 4.8 of the SmPC and section 2 and 4 of patient information leaflet to bring in line with the PRAC recommendation (PSUSA/02125/202308) regarding the drug reaction with eosinophilia and systemic symptoms (DRESS) and fixed drug eruption.
Last updated on this site: 15 Aug 2024
To update sections 4.4 and 4.8 of the SmPC and section 2 and 4 of patient information leaflet to bring in line with the PRAC recommendation (PSUSA/02125/202308) regarding the drug reaction with eosinophilia and systemic symptoms (DRESS) and fixed drug eruption.
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Changes: (Updated: 15 Aug 2024)
To update sections 4.4 and 4.8 of the SmPC and section 2 and 4 of patient information leaflet to bring in line with the PRAC recommendation (PSUSA/02125/202308) regarding the drug reaction with eosinophilia and systemic symptoms (DRESS) and fixed drug eruption.
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Changes: (Updated: 11 Jul 2024)
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8(ADR), 4.9, and 5.3 of the SmPC and PIL in line with reference product Naprosyn 250mg tablets (PL 43252/0004, MAH: Atnahs Pharma UK Ltd, SmPC dated 06/03/2024).
In addition typographical updates made in the PIL.
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Changes: (Updated: 07 Feb 2024)
Description of update: To update section 4.6 of the SPC in line with CMDH recommendation (EMA/CMDh/642745/2022- 29 July 2022). Consequently, the PIL has been updated.
SmPC Sections updated: 4.6 & 10.
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Changes: (Updated: 09 Nov 2022)
Updated
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Changes: (Updated: 21 Sep 2022)
initial upload