SmPC- Isosorbide Dinitrate Tablets BP 10mg: Change history

Last updated on this site: 06 Oct 2023

Description of update: To update sections 4.7 and 4.8 of the SmPC in line with the

reference product, Isoket Retard 20mg Tablets (MA Number:

PL 20011/0048; MAH: Norgine Pharmaceuticals Limited;

02/06/2023).

SmPC sections updated: 4.7, 4.8 and 10.

Changes: (Updated: 06 Oct 2023)

Description of update: To update sections 4.7 and 4.8 of the SmPC in line with the
reference product, Isoket Retard 20mg Tablets (MA Number:
PL 20011/0048; MAH: Norgine Pharmaceuticals Limited;
02/06/2023).
SmPC sections updated: 4.7, 4.8 and 10.
Changes: (Updated: 27 Jul 2023)

Variation Description: To register section 3.2.P.7 Container Closure System for 20μ Aluminium/250μ PVC blister packaging and to remove reference to the heat seal lacquer from section 6.5 of the SmPC
Changes: (Updated: 20 Sep 2022)

initial upload

Changes: (Updated: 06 Oct 2023)