PIL- Brinzolamide 10mg/ml Eye Drops, Suspension: Change history
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.
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.
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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.
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Changes: (Updated: 20 Sep 2022)
Initial upload