PIL - Pirfenidone 267 mg, 801 mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Pirfenidone 267 mg, 801 mg Film-coated Tablets)
Last updated on this site: 18 Nov 2024
IA, B.II.e.4.a - To register a change in blister count from 21 count to 7 count for the finished product.
Consequently, label, leaflets and section 6.5 of the SPC has been updated.
Last updated on this site: 18 Nov 2024
IA, B.II.e.4.a - To register a change in blister count from 21 count to 7 count for the finished product.
Consequently, label, leaflets and section 6.5 of the SPC has been updated.
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Changes: (Updated: 18 Nov 2024)
IA, B.II.e.4.a - To register a change in blister count from 21 count to 7 count for the finished product.
Consequently, label, leaflets and section 6.5 of the SPC has been updated.
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Changes: (Updated: 02 May 2024)
Description of update:
Update manufacturer to:
Accord-UK Ltd., Whiddon Valley, Barnstaple, Devon, EX32 8NS.
PIL sections updated: 6 only.
No changes to SmPC.
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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.
PIL sections updated: Header, 1, 2, 4 and 6.
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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.
PIL sections updated – 2, 5 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload