SmPC - Propranolol Tablets BP 40mg: Change history
View Summary of Product Characteristics (SmPC - Propranolol Tablets BP 40mg)
Last updated on this site: 03 Oct 2024
To update section 3 of the SmPC to add the description Pink, circular, biconvex film-coated tablets impressed "C" on one face and the identifying letters "P" and "B" on either side of a central division line on the reverse for 40mg dosage strength and Pink, circular, biconvex film-coated tablets impressed "C" on one face and the identifying letters "P" and "C" on either side of a central division line on the reverse for 80mg dosage strength in line with registered Module 3 sections 3.2.P.1 and 3.2.P.5.1.
Last updated on this site: 03 Oct 2024
To update section 3 of the SmPC to add the description Pink, circular, biconvex film-coated tablets impressed "C" on one face and the identifying letters "P" and "B" on either side of a central division line on the reverse for 40mg dosage strength and Pink, circular, biconvex film-coated tablets impressed "C" on one face and the identifying letters "P" and "C" on either side of a central division line on the reverse for 80mg dosage strength in line with registered Module 3 sections 3.2.P.1 and 3.2.P.5.1.
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Changes: (Updated: 03 Oct 2024)
To update section 3 of the SmPC to add the description Pink, circular, biconvex film-coated tablets impressed "C" on one face and the identifying letters "P" and "B" on either side of a central division line on the reverse for 40mg dosage strength and Pink, circular, biconvex film-coated tablets impressed "C" on one face and the identifying letters "P" and "C" on either side of a central division line on the reverse for 80mg dosage strength in line with registered Module 3 sections 3.2.P.1 and 3.2.P.5.1.
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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: 21 Sep 2022)
Initial upload