SmPC - Nitrazepam 5mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Nitrazepam 5mg Tablets)
Last updated on this site: 08 Oct 2024
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SPC in line with reference product, Mogadon 5 mg Tablets, PL 46302/0135, MAH: Mylan Products Ltd. Consequently, the PIL is updated.
Last updated on this site: 08 Oct 2024
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SPC in line with reference product, Mogadon 5 mg Tablets, PL 46302/0135, MAH: Mylan Products Ltd. Consequently, the PIL is updated.
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Changes: (Updated: 08 Oct 2024)
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SPC in line with reference product, Mogadon 5 mg Tablets, PL 46302/0135, MAH: Mylan Products Ltd. Consequently, the PIL is updated.
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Changes: (Updated: 31 May 2023)
Description of update: 1) To register section 3.2.P.7 of the dossier to reflect details of the blister packaging material. 2) To remove reference to the heat seal lacquer from section 6.5 of the SmPC.
There have been no changes to the blister packaging material itself, only an update in the supporting dossier details. There are no changes to the leaflet and labelling text.
SmPC section(s) updated– 6.5, 10
No changes to artwork
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Changes: (Updated: 20 Sep 2022)
Initial upload