SmPC - Mycophenolate Mofetil 500 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Mycophenolate Mofetil 500 mg Film-coated Tablets)
Last updated on this site: 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.
SmPC sections updated: 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
Approval date: 28/03/2026
Last updated on this site: 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.
SmPC sections updated: 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
Approval date: 28/03/2026
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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.
SmPC sections updated: 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
Approval date: 28/03/2026
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Changes: (Updated: 16 Jul 2024)
To update SmPC section 4.6 to implement the wording agreed by the CHMP following the outcome of the PSUR procedure EMEA/H/C/PSUSA/10550/202305.
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Changes: (Updated: 30 Nov 2023)
Description of update: To update SmPC sections 4.6, 4.8, 5.1, 5.2 and 5.3 and leaflet section 2 and 3 in-line with the information of reference product (Cellcept 500mg Film-Coated Tablets, MAH: Roche Registration GmbH, Germany; EU procedure number: EMEA/H/C/000082).
SmPC Sections updated: 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3.
PIL sections updated: Title, 1, 2, 3 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload