SmPC- Isosorbide Dinitrate Tablets BP 20mg: Change history
View Summary of Product Characteristics (SmPC- Isosorbide Dinitrate Tablets BP 20mg)
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.
View Summary of Product Characteristics (SmPC- Isosorbide Dinitrate Tablets BP 20mg)
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.
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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.
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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.
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Changes: (Updated: 20 Sep 2022)
initial upload