SmPC - Fluoxetine 20mg Capsules: Change history
View Summary of Product Characteristics (SmPC - Fluoxetine 20mg Capsules)
Last updated on this site: 18 Oct 2023
Description of update: To update section 5.1 of the SmPC in line with reference product, Prozac 20mg hard capsules (MA number: 34009 331008 9 6; MAH: Lilly France; dated: 22/01/2021). Consequently, the PIL has been updated. Additionally, the pharmacotherapeutic group name in SmPC section 5.1 has been updated in line with the WHO ATC Index and section 1 of the SmPC and the PIL have been updated in line with QRD template. The PIL headline has also been updated in line with MHRA guidelines for SSRIs (‘Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines’ (September 2019)) and editorial updates have been made to the PIL.
SmPC sections updated: 1, 5.1 and 10.
Last updated on this site: 18 Oct 2023
Description of update: To update section 5.1 of the SmPC in line with reference product, Prozac 20mg hard capsules (MA number: 34009 331008 9 6; MAH: Lilly France; dated: 22/01/2021). Consequently, the PIL has been updated. Additionally, the pharmacotherapeutic group name in SmPC section 5.1 has been updated in line with the WHO ATC Index and section 1 of the SmPC and the PIL have been updated in line with QRD template. The PIL headline has also been updated in line with MHRA guidelines for SSRIs (‘Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines’ (September 2019)) and editorial updates have been made to the PIL.
SmPC sections updated: 1, 5.1 and 10.
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Changes: (Updated: 18 Oct 2023)
Description of update: To update section 5.1 of the SmPC in line with reference product, Prozac 20mg hard capsules (MA number: 34009 331008 9 6; MAH: Lilly France; dated: 22/01/2021). Consequently, the PIL has been updated. Additionally, the pharmacotherapeutic group name in SmPC section 5.1 has been updated in line with the WHO ATC Index and section 1 of the SmPC and the PIL have been updated in line with QRD template. The PIL headline has also been updated in line with MHRA guidelines for SSRIs (‘Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines’ (September 2019)) and editorial updates have been made to the PIL.
SmPC sections updated: 1, 5.1 and 10.
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Changes: (Updated: 23 Aug 2023)
Website administration update only- no change to file
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Changes: (Updated: 21 Sep 2022)
Initial upload