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SmPC - Rizatriptan 10mg Orodispersible Tablets: Change history

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  • View Summary of Product Characteristics (SmPC - Rizatriptan 10mg Orodispersible Tablets)

    Last updated on this site: 09 Aug 2024

    To update section 4.6 of the SPC in line with PSUSA/00002655/202306. Consequently the PIL is updated.

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    • Changes: (Updated: 09 Aug 2024)

      To update section 4.6 of the SPC in line with PSUSA/00002655/202306. Consequently the PIL is updated.

    • Changes: (Updated: 10 Feb 2023)

      Variation Description:

      To update SPC sections 2 and 4.4 following request from MHRA in grant letter, ref: PL 00142/0978 - 0005, dated 10/09/2020.

      Additionally, further updates have been made in line with the latest EC Excipient guidance (version 10.2) which includes update to the aspartame warning wording in SPC section 4.4, and removal of mannitol warning from SPC section 4.4 and PIL as mannitol content per tablet, and for maximum daily allowance, is under the threshold of 10g.

       SmPC sections updated – 2, 4.4 and 10.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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