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SmPC - Prasugrel Accord 5mg Film-coated Tablets: Change history

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  • View Summary of Product Characteristics (SmPC - Prasugrel Accord 5mg Film-coated Tablets)

    Last updated on this site: 03 Aug 2023

    An Unlimited MA has been granted

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    • Changes: (Updated: 03 Aug 2023)

      An Unlimited MA has been granted

    • Changes: (Updated: 21 Jul 2023)

      Renewal approval. Update to SmPC sections 9 and 10 only.

    • Changes: (Updated: 06 Jul 2023)

      Variation Description: SmPC section 4.4 has been updated in line with the reference product Efient (EMEA/H/C/000984) and the excipient guideline. Consequential update to the PIL. SmPC section 2 has been updated to include the excipient sucrose stearate.

       

      SmPC sections updated – 2, 4.4 and 10

      PIL sections updated – Heading, 2, 5 and 6

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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