SmPC - Co-dydramol Tablets BP 10/500mg: Change history
View Summary of Product Characteristics (SmPC - Co-dydramol Tablets BP 10/500mg)
Last updated on this site: 13 May 2025
To update sections 4.4, 4.5 and 4.8 of the SmPC and PIL in line with the PRAC recommendation EMA/PRAC/499604/2024
Last updated on this site: 13 May 2025
To update sections 4.4, 4.5 and 4.8 of the SmPC and PIL in line with the PRAC recommendation EMA/PRAC/499604/2024
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Changes: (Updated: 13 May 2025)
To update sections 4.4, 4.5 and 4.8 of the SmPC and PIL in line with the PRAC recommendation EMA/PRAC/499604/2024
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Changes: (Updated: 26 Nov 2024)
II C.I.2.b
To update sections 4.4, 4.5, 4.6, 4.8 and 5.2 of the SPC in
line with reference product Co-dydramol 10mg/500mg Tablets
(MA number: PL 00010/021 PL 17780/0070 1; MAH: Zentiva
Pharma UK Limited; Dated: 17/01/2024).Consequently, the PIL
and label-leaflet are updated.
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Changes: (Updated: 27 Apr 2023)
Single Variation
Variation Type: IB, C.I.z
Variation Description: To update section 4.8 of the SmPC and the PIL in line with a request from the MHRA to include information regarding abdominal pain.
SmPC sections updated – 4.8 and 10
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Changes: (Updated: 22 Sep 2022)
initial upload