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PIL - Mycophenolate mofetil 250mg Capsules: Change history

  • 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

    • 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

    • 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.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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