SmPC- Isosorbide mononitrate Tablets 40mg: Change history
View Summary of Product Characteristics (SmPC- Isosorbide mononitrate Tablets 40mg)
Last updated on this site: 04 Sep 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.
Last updated on this site: 04 Sep 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: 04 Sep 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: 01 Sep 2023)
To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1 and 5.2 in line with innovator product i.e., Elantan 20/40 mg Tablets of Merus Labs.
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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