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Intended for UK patients and members of the public

Dorzolamide/Timolol 20mg/ml + 5mg/ml Eye Drops, Solution

PL Number:
0142/0988
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update: To update sections 4.2 and 4.8 of the SmPC in line with reference product COSOPT® 20 mg/ml + 5 mg/ml, eye drops, solution (MA Number: PL 16058/0016; MAH: Santen Oy; Dated: 12/07/2023). Consequently, the PIL has been updated. In addition, editorial updates have been made to section 4.8 of the SPC and PIL. The carton has been updated to add `UK Only' in line with the Windsor Framework guidance. The PIL and carton have been updated in line with MHRA warning guidelines: 'Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines', with additional QRD and formatting updates to the PIL.

    SmPC Sections updated: 4.2, 4.8 and 10.

  • Description of update: To update sections 4.2 and 4.8 of the SmPC in line with reference product COSOPT® 20 mg/ml + 5 mg/ml, eye drops, solution (MA Number: PL 16058/0016; MAH: Santen Oy; Dated: 12/07/2023). Consequently, the PIL has been updated. In addition, editorial updates have been made to section 4.8 of the SPC and PIL. The carton has been updated to add `UK Only' in line with the Windsor Framework guidance. The PIL and carton have been updated in line with MHRA warning guidelines: 'Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines', with additional QRD and formatting updates to the PIL.

    PIL sections updated: Heading, 2, 4 and 6.

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

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