SmPC - Diazepam Tablets BP 5mg: Change history
View Summary of Product Characteristics (SmPC - Diazepam Tablets BP 5mg)
Last updated on this site: 26 Oct 2023
Description of update: To update section 6.1 of the SmPC and section 6 of the PIL by adding a missing excipient - pregelatinised maize starch. Minor editorial changes are also made to the PIL to correct typographical errors.
SmPC sections updated: 6.1 and 10.
Last updated on this site: 26 Oct 2023
Description of update: To update section 6.1 of the SmPC and section 6 of the PIL by adding a missing excipient - pregelatinised maize starch. Minor editorial changes are also made to the PIL to correct typographical errors.
SmPC sections updated: 6.1 and 10.
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Changes: (Updated: 26 Oct 2023)
Description of update: To update section 6.1 of the SmPC and section 6 of the PIL by adding a missing excipient - pregelatinised maize starch. Minor editorial changes are also made to the PIL to correct typographical errors.
SmPC sections updated: 6.1 and 10.
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Changes: (Updated: 23 Jun 2023)
Variation Description: To update the PIL to bring in line with the QRD template (version 10.3) and to bring in line with the SmPC. Update to the PIL lactose excipient wording in line with the latest EC Excipient Guidance (version 10.2). Update to ATC code in SmPC section 5.1, in line with the WHO ATC Index. Additional QRD updates to SmPC sections 1, 3, 4.1, 4.2 (10mg only), 5.1, 6.1, 6.6 (2mg only), 7 (2mg only), 8 (2mg only), 9 (2mg only) and 10 (2mg only). Additional minor typographical and editorial changes to the PIL as well as to SmPC sections 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.7, 5.2 (5mg only) and 6.1 (2 & 5mg only).
SmPC sections updated – 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.7, 5.1, 5.2 (5mg), 6.1 (2 & 5mg), 6.6 (2mg), 7 (2mg), 8 (2mg), 9 (2mg) and 10.
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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.
SmPC section(s) updated– 6.5, 10
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Changes: (Updated: 20 Sep 2022)
Initial upload