SmPC - Dihydrocodeine Tablets BP 30mg: Change history
View Summary of Product Characteristics (SmPC - Dihydrocodeine Tablets BP 30mg)
Last updated on this site: 09 Apr 2025
To update SmPC sections 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 4.9, 5.1 in
line with reference product Dihydrocodeine 60 mg, prolonged
release tablets (MA number: 55612/0068; MAH: Ennogen IP
Ltd; Dated: 31/07/2024). Consequentially, the PIL has been
updated.
In addition, there are editorial updates to SmPC sections 4.2, 4.5, 4.8 and the PIL.
Last updated on this site: 09 Apr 2025
To update SmPC sections 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 4.9, 5.1 in
line with reference product Dihydrocodeine 60 mg, prolonged
release tablets (MA number: 55612/0068; MAH: Ennogen IP
Ltd; Dated: 31/07/2024). Consequentially, the PIL has been
updated.
In addition, there are editorial updates to SmPC sections 4.2, 4.5, 4.8 and the PIL.
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Changes: (Updated: 09 Apr 2025)
To update SmPC sections 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 4.9, 5.1 in
line with reference product Dihydrocodeine 60 mg, prolonged
release tablets (MA number: 55612/0068; MAH: Ennogen IP
Ltd; Dated: 31/07/2024). Consequentially, the PIL has been
updated.
In addition, there are editorial updates to SmPC sections 4.2, 4.5, 4.8 and the PIL.
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Changes: (Updated: 18 May 2023)
Description of update: To register M.3.2.P.7 Container Closure System for 20μ Aluminium/250μ PVC blister packaging. Amendments are also made to 3.2.P.1 and SmPC section 6.5.
Note: 3.2.P.1 and SmPC 6.5 have been updated to remove details of heat seal lacquer.
SmPC section(s) updated– 6.5, 10
(No changes to artwork)
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Changes: (Updated: 20 Sep 2022)
Initial upload