SmPC- Naproxen Tablets BP 500mg (PL 0142/0278): Change history
View Summary of Product Characteristics (SmPC- Naproxen Tablets BP 500mg (PL 0142/0278))
Last updated on this site: 15 Aug 2024
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/00002125/202308) for adverse effects drug reaction with eosinophilia and systemic symptoms (DRESS), and fixed drug eruption (FDE).
Consequentially, the patient information leaflet has been updated.
Last updated on this site: 15 Aug 2024
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/00002125/202308) for adverse effects drug reaction with eosinophilia and systemic symptoms (DRESS), and fixed drug eruption (FDE).
Consequentially, the patient information leaflet has been updated.
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Changes: (Updated: 15 Aug 2024)
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/00002125/202308) for adverse effects drug reaction with eosinophilia and systemic symptoms (DRESS), and fixed drug eruption (FDE).
Consequentially, the patient information leaflet has been updated.
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Changes: (Updated: 31 May 2024)
Description of update: To update section 4.6 of the SPC and PIL for Naproxen Tablets BP 250 mg and 500 mg to bring in line with the Reference product Naprosyn 250mg tablets (PL 43252/0004, MAH: Atnahs Pharma UK Ltd). In addition, typographical updates have been made in the PIL.
SmPC Sections updated: 4.6 & 10.
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Changes: (Updated: 31 Jul 2023)
Variation Description: To update section 4.4 and 4.8 of the SmPC in line with the PRAC recommendation PSUSA/00001270/202204. Consequentially, the PIL is updated.
SmPC sections updated – 4.4, 4.8 and 10.
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Changes: (Updated: 10 May 2023)
Single Variation
Variation type: IB, B.II.e.1.z
Variation Description: To register a module 32p7 covering the PVC blister lidded with aluminium. SmPC section 6.5 has been updated deleting obsolete packing.
Note: Additionally, details of heat seal lacquer have been removed from SmPC Section 6.5.
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Changes: (Updated: 22 Feb 2023)
Variation Description:
To update SmPC section 4.6 and PIL of Naproxen BP 250 mg and 500 mg tablets in line with PRAC recommendations for all systemic NSAIDs use during pregnancy.
Additionally SmPC section 4.8 and PIL have been updated to correct the error from `toxic epidermal necrosis' to `toxic epidermal necrolysis' in line with IME term.
SmPC sections updated – 4.6, 4.8 and 10.
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Changes: (Updated: 21 Sep 2022)
initial upload