SmPC- Terbinafine 250mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Terbinafine 250mg Tablets)
Last updated on this site: 27 Apr 2023
Variation Description: To update SmPC section 4.4 in line with the EC guidelines on Excipients (EMA/CHMP/302620/2017) for sodium and QRD template, consequently section 2 of the PIL has been updated. Section 4 of the PIL has also been updated to remove duplicate side effects following request from the MHRA in grant letter MHRA ref: PL 00142/0628 – 0059, dated 09/10/2019. We have also taken this opportunity to move serious side effects under the correct frequency in line with SmPC section 4.8.
SmPC sections updated – 4.4 and 10.
Last updated on this site: 27 Apr 2023
Variation Description: To update SmPC section 4.4 in line with the EC guidelines on Excipients (EMA/CHMP/302620/2017) for sodium and QRD template, consequently section 2 of the PIL has been updated. Section 4 of the PIL has also been updated to remove duplicate side effects following request from the MHRA in grant letter MHRA ref: PL 00142/0628 – 0059, dated 09/10/2019. We have also taken this opportunity to move serious side effects under the correct frequency in line with SmPC section 4.8.
SmPC sections updated – 4.4 and 10.
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Changes: (Updated: 27 Apr 2023)
Variation Description: To update SmPC section 4.4 in line with the EC guidelines on Excipients (EMA/CHMP/302620/2017) for sodium and QRD template, consequently section 2 of the PIL has been updated. Section 4 of the PIL has also been updated to remove duplicate side effects following request from the MHRA in grant letter MHRA ref: PL 00142/0628 – 0059, dated 09/10/2019. We have also taken this opportunity to move serious side effects under the correct frequency in line with SmPC section 4.8.
SmPC sections updated – 4.4 and 10.
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Changes: (Updated: 22 Sep 2022)
initial upload