SmPC- Topiramate Accord Healthcare 100mg Film-coated Tablets: Change history

To correct the transcription error from embossed to debossed in description of core & coated tablets. Consequently, section 3 of the SmPC and the PIL have been updated.

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).

 SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2, 5.3 and 10.