SmPC - Voriconazole Accord 50 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Voriconazole Accord 50 mg Film-coated Tablets)
Last updated on this site: 11 May 2026
Update to sections 4.3, 4.5 and 4.8 of the SmPC to bring the product information in line with the reference products, VFEND 50 mg/200 mg film-coated tablets. Consequently, the PIL has been updated. Additionally, sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the leaflet have been updated with editorial updates.
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2
Variation Approval date: 01/05/2026
Last updated on this site: 11 May 2026
Update to sections 4.3, 4.5 and 4.8 of the SmPC to bring the product information in line with the reference products, VFEND 50 mg/200 mg film-coated tablets. Consequently, the PIL has been updated. Additionally, sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the leaflet have been updated with editorial updates.
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2
Variation Approval date: 01/05/2026
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Changes: (Updated: 11 May 2026)
Update to sections 4.3, 4.5 and 4.8 of the SmPC to bring the product information in line with the reference products, VFEND 50 mg/200 mg film-coated tablets. Consequently, the PIL has been updated. Additionally, sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the leaflet have been updated with editorial updates.
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2
Variation Approval date: 01/05/2026
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Changes: (Updated: 04 Sep 2025)
Description of update: To update sections 4.2, 4.3 and 4.5 of the SmPC in line with the reference product VFEND 50 mg/ 200 mg film-coated tablets; MAH: Pfizer Europe MA EEIG, Belgium. Consequently the PIL has been updated. Additionally, editorial changes are being made to sections 2, 3, 4.4, 4.8, 5.1, 5.2, 8 of the SmPC and the PIL.
Date of approval: 29/08/2025
SmPC sections updated: 2, 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 8 and 10
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Changes: (Updated: 15 Aug 2024)
IB C.I.2.a - To update sections 4.4, 4.5 and 4.8 of the SmPC in-line reference product, VFEND 50 mg/200 mg film-coated tablets; MAH: Pfizer Europe MA EEIG, Belgium; EU procedure number with outcome: EMEA/H/C/000387/WS/2270). Consequently, the PIL is updated. Additionally, section 4.8 and 5.1 of the SmPC have been updated with editorial changes in line with reference product information.
IB C.I.z - To update section 5.1 of the SmPC with Susceptibility testing breakpoints criteria in line with adoption of revision 3 of the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.
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Changes: (Updated: 18 Aug 2023)
Description of update: To update section 4.5 of the SmPC to implement the signal recommendations on `Voriconazole; flucloxacillin - Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels (EPITT No: 19849)' adopted at the 13-16 March 2023 PRAC meeting. Consequently, the PIL has been updated.
SmPC sections updated: 4.5, 10.
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Changes: (Updated: 07 Jun 2023)
Website administration update - no change to document content
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Changes: (Updated: 22 Sep 2022)
Initial upload