SmPC- Amitriptyline Tablets BP 50mg: Change history
View Summary of Product Characteristics (SmPC- Amitriptyline Tablets BP 50mg)
Last updated on this site: 09 Apr 2025
IB, C.I.3.z - Update to SPC sections 4.4, 4.8, and PIL in line with PRAC recommendations (PSUSA/00010374/202401) for causal relationship between DRESS and amitriptyline.
View Summary of Product Characteristics (SmPC- Amitriptyline Tablets BP 50mg)
Last updated on this site: 09 Apr 2025
IB, C.I.3.z - Update to SPC sections 4.4, 4.8, and PIL in line with PRAC recommendations (PSUSA/00010374/202401) for causal relationship between DRESS and amitriptyline.
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Changes: (Updated: 09 Apr 2025)
IB, C.I.3.z - Update to SPC sections 4.4, 4.8, and PIL in line with PRAC recommendations (PSUSA/00010374/202401) for causal relationship between DRESS and amitriptyline.
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Changes: (Updated: 30 Mar 2023)
Variation type: IB, B.II.e.1.z
Variation Description:
1. To register 3.2.P.7 Container Closure System - PVC/Al blister pack in line with current expectations and to improve compliance.
2. To remove details of heat seal lacquer from SmPC. Section 6.5 and section 3.2.P.1 are updated.
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Changes: (Updated: 20 Sep 2022)
initial upload