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: 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.
Last updated on this site: 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: 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