SmPC - Pirfenidone 801 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Pirfenidone 801 mg Film-coated Tablets)
Last updated on this site: 25 Apr 2024
Description of update:
1. To update sections 4.1, 4.8 and 5.1 of the SmPC in line with the reference product Esbriet 267, 534, 801mg film-coated tablets (PLGB 00031/0852, 0853, 0854; MAH: Roche Products Limited) dated 5th December 2023. Consequently, the PIL has been updated. Additionally, the PIL has been updated with editorial changes.
2. To update sections 4.4, 4.8 of the SmPC in line with the PRAC recommendation EPITT no. 19920 (DRESS syndrome). Consequently, the PIL has been updated.
SmPC Sections updated: 4.1, 4.4, 4.8, 5.1 and 10.
Last updated on this site: 25 Apr 2024
Description of update:
1. To update sections 4.1, 4.8 and 5.1 of the SmPC in line with the reference product Esbriet 267, 534, 801mg film-coated tablets (PLGB 00031/0852, 0853, 0854; MAH: Roche Products Limited) dated 5th December 2023. Consequently, the PIL has been updated. Additionally, the PIL has been updated with editorial changes.
2. To update sections 4.4, 4.8 of the SmPC in line with the PRAC recommendation EPITT no. 19920 (DRESS syndrome). Consequently, the PIL has been updated.
SmPC Sections updated: 4.1, 4.4, 4.8, 5.1 and 10.
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Changes: (Updated: 25 Apr 2024)
Description of update:
1. To update sections 4.1, 4.8 and 5.1 of the SmPC in line with the reference product Esbriet 267, 534, 801mg film-coated tablets (PLGB 00031/0852, 0853, 0854; MAH: Roche Products Limited) dated 5th December 2023. Consequently, the PIL has been updated. Additionally, the PIL has been updated with editorial changes.
2. To update sections 4.4, 4.8 of the SmPC in line with the PRAC recommendation EPITT no. 19920 (DRESS syndrome). Consequently, the PIL has been updated.
SmPC Sections updated: 4.1, 4.4, 4.8, 5.1 and 10.
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Changes: (Updated: 27 Apr 2023)
Description of update: To extend the drug product shelf-life from 24 months to 36 months.
SmPC sections updated: 6.3, 10.
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Changes: (Updated: 22 Mar 2023)
Variation Description: To update sections 4.4, 4.8 and 5.2 of the SmPC in line with the reference product Esbriet 267, 534, 801mg film-coated tablets (PLGB 00031/0852, 0853, 0854 - MAH: Roche Products Limited) dated 11th February 2022. Consequently, the Patient Information Leaflet has also been updated.
SmPC sections updated – 4.4, 4.8, 5.2 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload