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Intended for UK patients and members of the public

PIL- Exemestane 25mg Film-coated Tablets: Change history

  • The following changes have been notified:

     

    • Type IAin, B.II.b.1.a - Addition of Accord Healthcare single member S.A. as secondary packaging site.

    • Type IAin, B.II.b.2.c.2 - Addition of Accord Healthcare single member S.A. as manufacturer responsible for importation and batch release - Including batch control/testing.

     

    The application is accepted on 19 May 2025.

    • Changes: (Updated: 20 May 2025)

      The following changes have been notified:

       

      • Type IAin, B.II.b.1.a - Addition of Accord Healthcare single member S.A. as secondary packaging site.

      • Type IAin, B.II.b.2.c.2 - Addition of Accord Healthcare single member S.A. as manufacturer responsible for importation and batch release - Including batch control/testing.

       

      The application is accepted on 19 May 2025.

    • Changes: (Updated: 25 Apr 2023)

      Description of update: The proposed change is: C.I.2.a: Update of SmPC and PIL in-line with reference product information: Aro-masin 25 mg coated tablets; Procedure number: NL/H/4752/001/DC; MAH: Pfizer Healthcare Ireland, Dublin.

      PIL sections updated: 2, 3, 4, 6.

    • Changes: (Updated: 02 Dec 2022)

      Change to section 1 - what the product is

      Change to section 2 - what you need to know - warnings and precautions

      Change to section 2 - interactions with other medicines, food or drink

      Change to section 2 - driving and using machines

      Change to section 4 - possible side effects

      Change to section 6 - date of revision

    • Changes: (Updated: 20 Sep 2022)

      initial upload

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