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PIL- Glimepiride 1mg, 2mg, 3mg, 4mg Tablets: Change history

    • Type IA (B.II.b.2.a) To add Labanalysis Life Science S.r.l. Via Europa 5, Casanova Lonati, 27041, Italy as an alternative site responsible for batch control/testing of the finished product.

    • Type IAIN (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.

    • Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

      Consequently, the PIL is updated.

    • Changes: (Updated: 06 Nov 2025)

      • Type IA (B.II.b.2.a) To add Labanalysis Life Science S.r.l. Via Europa 5, Casanova Lonati, 27041, Italy as an alternative site responsible for batch control/testing of the finished product.

      • Type IAIN (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.

      • Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

        Consequently, the PIL is updated.

    • Changes: (Updated: 09 Aug 2023)

      Update section  4.2, 4.3, 4.6, 4.8, 4.9, and 5.1 of SmPC and section 1, 2, 3 and 4 of PIL information in line with the information of Reference product (AMARYL 1 mg, 2 mg, 3 mg, 4 mg.

    • Changes: (Updated: 20 Sep 2022)

      initial upload

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