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PIL- Brinzolamide 10mg/ml Eye Drops, Suspension: Change history

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  • View Patient Information Leaflet (PIL- Brinzolamide 10mg/ml Eye Drops, Suspension)

    Last updated on this site: 15 Aug 2024

    SmPC 4.2, 4.6, 5.3 and the PIL have been updated in line with the reference product Azopt. Additional editorial updates have been made to the PIL.

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    • Changes: (Updated: 15 Aug 2024)

      SmPC 4.2, 4.6, 5.3 and the PIL have been updated in line with the reference product Azopt. Additional editorial updates have been made to the PIL.

    • Changes: (Updated: 13 May 2024)

      Description of update:

      IB, B.II.b.1.z - The Gamma irradiation dose and bioburden limits adopted by new alternative sterilization sites are set to 17.5 - 50 kGy and Max 9 CFU, respectively.

      IB, B.II.b.1.z - Addition of manufacturing site BGS Beta-Gamma-Service GmbH & Co. KG, John-Deere-Straße 1 + 3, 76646 Bruchsal, Germany is introduced as alternative sterilization sites for all primary packaging components (i.e., bottles, droppers & caps).

      IB, B.II.b.1.z - Addition of manufacturing site BGS Beta-Gamma-Service GmbH & Co. KG, Fritz-Kotz-Strasse 12 + 16, 51674 Wiehl, Germany, is introduced as alternative sterilization sites for all primary packaging components (i.e., bottles, droppers & caps).

      IB, B.II.e.4.c - Change in shape or dimensions of the container or closure (immediate packaging) - Sterile medicinal products - change the size/capacity of the primary container (bottle only) from 5ml to 10ml.

      PIL sections updated: 6 only.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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