PIL - Nitrazepam 5mg Tablets: Change history
View Patient Information Leaflet (PIL - Nitrazepam 5mg Tablets)
Last updated on this site: 04 Mar 2026
Description of update: To update SmPC sections 4.2, 4.4, 4.8, 4.9, PIL sections: Introduction, 1, 2, 3, 4, 6 and labelling (carton) section 7 in line with MHRA final recommendations.
Date of approval: 26/02/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
Last updated on this site: 04 Mar 2026
Description of update: To update SmPC sections 4.2, 4.4, 4.8, 4.9, PIL sections: Introduction, 1, 2, 3, 4, 6 and labelling (carton) section 7 in line with MHRA final recommendations.
Date of approval: 26/02/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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Changes: (Updated: 04 Mar 2026)
Description of update: To update SmPC sections 4.2, 4.4, 4.8, 4.9, PIL sections: Introduction, 1, 2, 3, 4, 6 and labelling (carton) section 7 in line with MHRA final recommendations.
Date of approval: 26/02/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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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: 20 Sep 2022)
Initial upload