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Intended for UK patients and members of the public

Brinzolamide Eye Drops

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Brinzolamide 10mg/ml Eye Drops, Suspension

PL Number:
0142/0985
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

    SmPC Sections updated: 6.5 & 10.

  • 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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