SmPC - Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection: Change history
View Summary of Product Characteristics (SmPC - Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection)
Last updated on this site: 12 Nov 2025
Update to SPC and PIL for causal relationship between diamorphine and opioid use disorders, sleep-related breathing disorders, and interactions with gabapentinoids and anticholinergics in line with PSUSA/00001028/202411 for products with pain indication.
Variation approved 04/11/2025
SmPC sections updated 4.4, 4.5, 4.8 and 10
Last updated on this site: 12 Nov 2025
Update to SPC and PIL for causal relationship between diamorphine and opioid use disorders, sleep-related breathing disorders, and interactions with gabapentinoids and anticholinergics in line with PSUSA/00001028/202411 for products with pain indication.
Variation approved 04/11/2025
SmPC sections updated 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 12 Nov 2025)
Update to SPC and PIL for causal relationship between diamorphine and opioid use disorders, sleep-related breathing disorders, and interactions with gabapentinoids and anticholinergics in line with PSUSA/00001028/202411 for products with pain indication.
Variation approved 04/11/2025
SmPC sections updated 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 03 Jul 2025)
Renewal. Date of renewal 18/12/2024
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Changes: (Updated: 21 Jul 2023)
Website administration update
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Changes: (Updated: 20 Sep 2022)
Initial upload