PIL- Topiramate Accord Healthcare 25mg, 50mg, 100mg, 200mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL- Topiramate Accord Healthcare 25mg, 50mg, 100mg, 200mg Film-coated Tablets)
Last updated on this site: 13 Mar 2023
Variation Description:
To update sections 4.2, 4.4 and 5.1 of the SPC in line with reference product, Topamax 25, 50, 100, 200mg film-coated tablets (PL 00242/0301-4; MAH: Janssen-Cilag Ltd; dated 16/09/2022). Consequently, the PIL has been updated.
Additional updates have been made to the SPC and Label:
To update typographical and text formatting in sections 4.1, 4.5, 4.6, 4.7, 4.8, 5.2 and 5.3 of the SPC.
To make amendment to the ‘Excipients’ information in section 4.4 of the SPC to be specific for each strength.
To update the ATC level name in section 5.1 of the SPC.
To update the braille on the cartons for hyphen in line with United English Braille (UEB).
PIL sections updated – Index, 1, 2, 4, 5 and 6.
Last updated on this site: 13 Mar 2023
Variation Description:
To update sections 4.2, 4.4 and 5.1 of the SPC in line with reference product, Topamax 25, 50, 100, 200mg film-coated tablets (PL 00242/0301-4; MAH: Janssen-Cilag Ltd; dated 16/09/2022). Consequently, the PIL has been updated.
Additional updates have been made to the SPC and Label:
To update typographical and text formatting in sections 4.1, 4.5, 4.6, 4.7, 4.8, 5.2 and 5.3 of the SPC.
To make amendment to the ‘Excipients’ information in section 4.4 of the SPC to be specific for each strength.
To update the ATC level name in section 5.1 of the SPC.
To update the braille on the cartons for hyphen in line with United English Braille (UEB).
PIL sections updated – Index, 1, 2, 4, 5 and 6.
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Changes: (Updated: 13 Mar 2023)
Variation Description:
To update sections 4.2, 4.4 and 5.1 of the SPC in line with reference product, Topamax 25, 50, 100, 200mg film-coated tablets (PL 00242/0301-4; MAH: Janssen-Cilag Ltd; dated 16/09/2022). Consequently, the PIL has been updated.
Additional updates have been made to the SPC and Label:
To update typographical and text formatting in sections 4.1, 4.5, 4.6, 4.7, 4.8, 5.2 and 5.3 of the SPC.
To make amendment to the ‘Excipients’ information in section 4.4 of the SPC to be specific for each strength.
To update the ATC level name in section 5.1 of the SPC.
To update the braille on the cartons for hyphen in line with United English Braille (UEB).
PIL sections updated – Index, 1, 2, 4, 5 and 6.
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Changes: (Updated: 22 Sep 2022)
initial upload