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SmPC- Telmisartan/Hydrochlorothiazide 80mg/12.5mg Tablets: Change history

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  • View Summary of Product Characteristics (SmPC- Telmisartan/Hydrochlorothiazide 80mg/12.5mg Tablets)

    Last updated on this site: 13 May 2025

    Update to SmPC sections 4.4, 4.8 and PIL sections 2 and 4 in line with PRAC recommendations (EPITT No 20104) for intestinal angioedema.

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    • Changes: (Updated: 13 May 2025)

      Update to SmPC sections 4.4, 4.8 and PIL sections 2 and 4 in line with PRAC recommendations (EPITT No 20104) for intestinal angioedema.

    • Changes: (Updated: 14 Apr 2023)

      Variation description: Type IB (C.I.3.z) variation application to update SmPC section 5.3 for `incresed risk of skin cancer' as per CMDh minutes for the meeting updated on 8-10 November 2022.

      SmPC sections updated: 5.3, 9, 10.

    • Changes: (Updated: 22 Sep 2022)

      initial upload

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