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: 15 Jul 2025
Renewal. Renewal approval date 11/07/2025
View Summary of Product Characteristics (SmPC- Naproxen 250mg Gastro-resistant Tablets (PL 20075/0619))
Last updated on this site: 15 Jul 2025
Renewal. Renewal approval date 11/07/2025
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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
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Changes: (Updated: 22 Sep 2022)
initial upload