SmPC - Phenytoin sodium NRIM 100mg Capsules: Change history
View Summary of Product Characteristics (SmPC - Phenytoin sodium NRIM 100mg Capsules)
Last updated on this site: 20 Jan 2023
Variation Description: Sections 4.4, 4.5, and 4.8 of the SmPC have been updated in line with the reference product Phenytoin Sodium Flynn 25, 50, 100, 300mg Hard Capsules (PL 13621/0061-0064, MAH: Flynn Pharma Ltd), dated 11th January 2022. Consequently, the PIL has been updated.
SmPC sections updated – 4.4, 4.5, 4.8 and 10.
Last updated on this site: 20 Jan 2023
Variation Description: Sections 4.4, 4.5, and 4.8 of the SmPC have been updated in line with the reference product Phenytoin Sodium Flynn 25, 50, 100, 300mg Hard Capsules (PL 13621/0061-0064, MAH: Flynn Pharma Ltd), dated 11th January 2022. Consequently, the PIL has been updated.
SmPC sections updated – 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 20 Jan 2023)
Variation Description: Sections 4.4, 4.5, and 4.8 of the SmPC have been updated in line with the reference product Phenytoin Sodium Flynn 25, 50, 100, 300mg Hard Capsules (PL 13621/0061-0064, MAH: Flynn Pharma Ltd), dated 11th January 2022. Consequently, the PIL has been updated.
SmPC sections updated – 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 23 Dec 2022)
Variation Description: To update sections 4.6 and 5.3 of the SmPC and PIL in line with the MHRA recommendation for the safety of use during pregnancy of antiepileptic drugs, dated 13th August 2021.
SmPC sections updated – 4.6, 5.3 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload