SmPC - Piroxicam Capsules 20mg: Change history
View Summary of Product Characteristics (SmPC - Piroxicam Capsules 20mg)
Last updated on this site: 03 Mar 2026
Description of update: To update sections 4.3, 4.4, 4.6, 4.8, 5.1 and 5.2 of the SmPC in line with reference product Feldene 20mg Capsules. Consequently, the PIL has been updated. In addition, there are formatting updates to SmPC sections 4.3, 4.8 and 5.1 and there are editorial updates to SmPC section 4.4.
Date of approval: 24/02/2026
SmPC sections updated: 4.3, 4.4, 4.6, 4.8, 5.1, 5.2 and 10
Last updated on this site: 03 Mar 2026
Description of update: To update sections 4.3, 4.4, 4.6, 4.8, 5.1 and 5.2 of the SmPC in line with reference product Feldene 20mg Capsules. Consequently, the PIL has been updated. In addition, there are formatting updates to SmPC sections 4.3, 4.8 and 5.1 and there are editorial updates to SmPC section 4.4.
Date of approval: 24/02/2026
SmPC sections updated: 4.3, 4.4, 4.6, 4.8, 5.1, 5.2 and 10
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Changes: (Updated: 03 Mar 2026)
Description of update: To update sections 4.3, 4.4, 4.6, 4.8, 5.1 and 5.2 of the SmPC in line with reference product Feldene 20mg Capsules. Consequently, the PIL has been updated. In addition, there are formatting updates to SmPC sections 4.3, 4.8 and 5.1 and there are editorial updates to SmPC section 4.4.
Date of approval: 24/02/2026
SmPC sections updated: 4.3, 4.4, 4.6, 4.8, 5.1, 5.2 and 10
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Changes: (Updated: 02 Dec 2024)
To update sections 4.8 and 4.9 of the SPC in line with the reference product Feldene 20mg Capsules (PL 00057/0146; MAH: Pfizer Limited). Consequently, the PIL has been updated.
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Changes: (Updated: 08 Feb 2023)
Variation Description: To register an update to sections 4.6 of the SmPC in line with PRAC recommendation (EMA/CMDh/642745/2022: NSAID-containing medicinal products (for systemic use) and use during pregnancy). Consequently, the leaflet has been updated.
SmPC sections updated – 4.6 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload