SmPC - Dorzolamide/Timolol 20mg/ml + 5mg/ml Eye Drops, Solution: Change history
View Summary of Product Characteristics (SmPC - Dorzolamide/Timolol 20mg/ml + 5mg/ml Eye Drops, Solution)
Last updated on this site: 14 Dec 2023
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.
Last updated on this site: 14 Dec 2023
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.
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Changes: (Updated: 14 Dec 2023)
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.
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Changes: (Updated: 23 Aug 2023)
Website administration update only- no change to file
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Changes: (Updated: 03 May 2023)
Variation Description: To update section 4.8 of the SmPC and sections 3 and 4 of PIL in line with PRAC recommendations (PRAC-PSUSA/00003168/202202). In addition section 4.6 of SmPC has been updated in line with the Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling "(EMEA/CHMP/203927/2005)" and in line with the QRD template. Additional editorial updates to SmPC sections 4.6, 4.8 and PIL.
SmPC sections updated – 4.6, 4.8 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload