SmPC- Itraconazole 100mg Capsules, hard: Change history
View Summary of Product Characteristics (SmPC- Itraconazole 100mg Capsules, hard)
Last updated on this site: 12 Oct 2023
Description of update: IB, B.II.f.1.b.1 - Change of the shelf life of the finished product as packaged for sale (supported by real time data) from 24 months to 36 months.
SmPC sections updated: 6.3 and 10.
Last updated on this site: 12 Oct 2023
Description of update: IB, B.II.f.1.b.1 - Change of the shelf life of the finished product as packaged for sale (supported by real time data) from 24 months to 36 months.
SmPC sections updated: 6.3 and 10.
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Changes: (Updated: 12 Oct 2023)
Description of update: IB, B.II.f.1.b.1 - Change of the shelf life of the finished product as packaged for sale (supported by real time data) from 24 months to 36 months.
SmPC sections updated: 6.3 and 10.
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Changes: (Updated: 23 Dec 2022)
Variation description: To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8 of the SPC in line with the reference product Sporanox 100mg Capsules (PL 00242/0142; MAH: Janssen-Cilag Ltd; dated 17/08/2020). Consequentially, the leaflet has been updated.
Additional QRD and typographical amendments made to the PIL.
SmPC sections updated – 4.1, 4.2, 4.3, 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 20 Sep 2022)
initial upload