SmPC - Fluconazole 150mg Capsules: Change history
View Summary of Product Characteristics (SmPC - Fluconazole 150mg Capsules)
Last updated on this site: 15 Aug 2024
To update sections 4.5 & 5.1 of the SmPC to bring product information in line with the reference product Diflucan 50, 150, 200mg hard capsules 00057/0289, 0290, 0317, MA holder Pfizer Limited (updated 01/02/2024).
Also update to section 5.1 in line with EMA request to relocates the MIC data from the PI.
Last updated on this site: 15 Aug 2024
To update sections 4.5 & 5.1 of the SmPC to bring product information in line with the reference product Diflucan 50, 150, 200mg hard capsules 00057/0289, 0290, 0317, MA holder Pfizer Limited (updated 01/02/2024).
Also update to section 5.1 in line with EMA request to relocates the MIC data from the PI.
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Changes: (Updated: 15 Aug 2024)
To update sections 4.5 & 5.1 of the SmPC to bring product information in line with the reference product Diflucan 50, 150, 200mg hard capsules 00057/0289, 0290, 0317, MA holder Pfizer Limited (updated 01/02/2024).
Also update to section 5.1 in line with EMA request to relocates the MIC data from the PI.
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Changes: (Updated: 26 Feb 2024)
Description of update: To update section 4.6 of the SmPC in line with PSUSA/00001404/202303. Consequently, the PIL has been updated. Additionally, section 6 of the PIL has been updated to align with SmPC, and sections 4 and 5 have been updated to align with the latest QRD template, as well as editorial amends to the PIL for grammar, spelling, and typographical errors.
SmPC Sections updated: 4.6 and 10.
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Changes: (Updated: 07 Sep 2023)
To register an updated ATC code for the finished product following a WHO recommendation. Consequentially, section 5.1 of the SmPC has been updated.
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Changes: (Updated: 20 Jul 2023)
To update section 4.5 of the SmPC and sections 2 and 6 of the PIL in line with the reference product, Diflucan 50mg, 150mg, 200mg hard capsules (PL 00057/0289, PL 00057/0290, PL 00057/0317).
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Changes: (Updated: 13 Mar 2023)
Description of update: To update sections 4.5 and 4.6 of the SmPC and sections 2 and 6 of the PIL in line with the reference product Diflucan 50mg, 150mg, 200mg hard capsules (PL 00057/0289, PL 00057/0290, PL 00057/0317) of Zentiva Pharma UK Limited.
SmPC sections updated: 4.5, 4.6, 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload