SmPC - Dorzolamide 20mg/ml Eye Drops Solution: Change history
View Summary of Product Characteristics (SmPC - Dorzolamide 20mg/ml Eye Drops Solution)
Last updated on this site: 20 Feb 2026
Description of update: To update section 4.8 of the SmPC and PIL in line with PRAC recommendation (PSUSA/00003168/202502), to add photophobia as an adverse reaction.
Date of approval: 13/02/2026
SmPC sections updated: 4.8 and 10
Last updated on this site: 20 Feb 2026
Description of update: To update section 4.8 of the SmPC and PIL in line with PRAC recommendation (PSUSA/00003168/202502), to add photophobia as an adverse reaction.
Date of approval: 13/02/2026
SmPC sections updated: 4.8 and 10
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Changes: (Updated: 20 Feb 2026)
Description of update: To update section 4.8 of the SmPC and PIL in line with PRAC recommendation (PSUSA/00003168/202502), to add photophobia as an adverse reaction.
Date of approval: 13/02/2026
SmPC sections updated: 4.8 and 10
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Changes: (Updated: 06 Oct 2023)
Description of update: To update SmPC section 5.1 to align ATC level naming with the WHO ATC Index.
SmPC sections updated: 5.1 and 10.
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Changes: (Updated: 28 Apr 2023)
Variation Description: To update sections 4.2 and 4.8 of the SPC to bring in line with the PRAC recommendations (PRACPSUSA/00003168/202202). Consequently, the leaflet has been updated. Additionally, section 4.6 of the SPC has been updated; the brand name Trusopt has been replaced with dorzolamide and the product description in section 6 of the PIL has been updated in line with section 3 of the SPC.
SmPC sections updated – 4.2, 4.6, 4.8 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload