SmPC- Naproxen 250mg Gastro-resistant Tablets (PL 20075/0619): Change history
View Summary of Product Characteristics (SmPC- Naproxen 250mg Gastro-resistant Tablets (PL 20075/0619))
Last updated on this site: 05 Sep 2024
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/02125/202308) regarding adverse reactions DRESS and Fixed Drug Eruption. Consequently, the PIL has been updated.
Last updated on this site: 05 Sep 2024
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/02125/202308) regarding adverse reactions DRESS and Fixed Drug Eruption. Consequently, the PIL has been updated.
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Changes: (Updated: 05 Sep 2024)
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/02125/202308) regarding adverse reactions DRESS and Fixed Drug Eruption. Consequently, the PIL has been updated.
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Changes: (Updated: 11 Jul 2024)
Removal of beeswax in section 6.1
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Changes: (Updated: 02 May 2024)
Description of update: To register the deletion of Bestway Pharmacy NDC Limited (T/A Well Pharmaceuticals), Enterprise Way, Meir Park, Stoke-On-Trent, ST3 7UN, United Kingdom, as an Own Label Supplier for Period Pain Reliever 250mg Gastro-resistant Tablets, including the deletion of associated artwork. Consequently, section 1 of the SmPC has been updated.
SmPC Sections updated: 1 & 10.
No changes to PIL.
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Changes: (Updated: 27 Dec 2023)
Description of update:
To update sections 4.4, 4.7, 4.8, 4.9 and 5.1 of the SmPC fragment following the reference product comparison with the new reference product of Noumed Period Pain Relief 250 mg Gastro-Resistant Tablets. Consequently, the PIL is updated.
SmPC Sections updated: 4.4, 4.7, 4.8, 4.9, 5.1, and 10.
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Changes: (Updated: 06 Dec 2023)
Description of update: To add Maxwellia Ltd, Alderley Park, Alderley Edge, SK10 4TG, UK as Own Label Supplier with consequential addition of Own Label Supplier product name of Ultravana Period Pain Relief 250 mg Gastro-resistant tablets. Consequently, section 1 of the SmPC, label and Ultravana™ PIL has been updated.
SmPC Sections updated: 1 and 10.
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Changes: (Updated: 11 Aug 2023)
Description of update:
To add OTC Direct Limited (T/A Almus Pharmaceuticals), 43 Cox Lane, Chessington, KT9 1SN, United Kingdom as Own Label Supplier using own label and leaflet (with product name ‘Almus Period Pain Reliever 250mg Gastro-resistant Tablets’. Consequently, section 1 of the SmPC is updated.
SmPC sections updated: 1 & 10.
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Changes: (Updated: 28 Jun 2023)
Website Administration update only- no change to file.
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Changes: (Updated: 28 Jun 2023)
Variation Description: To update sections 4.4 and 4.8 of the SmPC to bring in line with PRAC recommendations (PSUSA/00001270/202204) for Esomeprazole-Naproxen for Tubulointerstitial nephritis. Consequently, the PIL has been updated.
SmPC sections updated – 4.4, 4.8 and 10.
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Changes: (Updated: 06 Apr 2023)
Variation Description:
To update section 4.6 of the SPC and PIL in line with PRAC recommendations for NSAIDs (for systemic use) and use during pregnancy.
In addition, typographical and editorial amendments have been made in the PIL.
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Changes: (Updated: 07 Dec 2022)
MA holder: Accord Healthcare Limited
Variation approval – 05.12.2022
Single Variation
Variation type: IB, B.II.b.1.z
Variation Description: To add Bestway Pharmacy NDC Limited (T/A Well Pharmaceuticals) as an Own Label Supplier under the product name of ‘Well Pharmaceuticals Period Pain Reliever 250 mg Gastro-resistant Tablets’. Consequently, section 1 of the SmPC, PIL and label have been updated.
SmPC section(s) updated – 1 and 10
No changes to PIL – new Well Pharmaceuticals PIL created