PIL - Mycophenolate mofetil 250mg Capsules: Change history
View Patient Information Leaflet (PIL - Mycophenolate mofetil 250mg Capsules)
Last updated on this site: 06 Aug 2026
Description of update: To update section 4.8 of the SmPC and section 4 of the leaflet to implement the wording agreed by PRAC following outcome of the PSUR procedure (PSUSA/00010550/202505). Additional Excipient and QRD updates have been included in the PIL.
Date of approval: 16/07/2026
PIL sections updated: 2, 4 and 6
Last updated on this site: 06 Aug 2026
Description of update: To update section 4.8 of the SmPC and section 4 of the leaflet to implement the wording agreed by PRAC following outcome of the PSUR procedure (PSUSA/00010550/202505). Additional Excipient and QRD updates have been included in the PIL.
Date of approval: 16/07/2026
PIL sections updated: 2, 4 and 6
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Changes: (Updated: 06 Aug 2026)
Description of update: To update section 4.8 of the SmPC and section 4 of the leaflet to implement the wording agreed by PRAC following outcome of the PSUR procedure (PSUSA/00010550/202505). Additional Excipient and QRD updates have been included in the PIL.
Date of approval: 16/07/2026
PIL sections updated: 2, 4 and 6
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Changes: (Updated: 02 Apr 2026)
To update product information for Mycophenolate in-line information with the reference product(CellCept 500 mg film-coated tablets; EU procedure number: EMEA/H/C/000082/II/0170/G; MAH Roche Registration GmbH, Germany) through work-sharing procedure.
PIL sections updated: 1, 2, 3, 4 and 6
Approval date: 28/03/2026
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Changes: (Updated: 29 Jul 2025)
The following change(s) has been notified:
1. Type IAIN (B.II.b.1.a) To add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.
Type IAIN (B.II.b.2.C.2) To add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
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Changes: (Updated: 21 Sep 2022)
Initial upload