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SmPC- Atorvastatin 80mg Film-coated Tablets (20075/0491): Change history

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  • View Summary of Product Characteristics (SmPC- Atorvastatin 80mg Film-coated Tablets (20075/0491))

    Last updated on this site: 18 Nov 2024

    IAIN, C.I.3.a - ­PSUSA/00010347/202310: causal relationship between myopathy and rhabdomyolysis following concomitant use of atorvastatin and daptomycin, between atorvastatin and lichenoid drug reaction, and between atorvastatin and vasculitis

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    • Changes: (Updated: 18 Nov 2024)

      IAIN, C.I.3.a - ­PSUSA/00010347/202310: causal relationship between myopathy and rhabdomyolysis following concomitant use of atorvastatin and daptomycin, between atorvastatin and lichenoid drug reaction, and between atorvastatin and vasculitis

    • Changes: (Updated: 15 Jun 2023)

      Description of update: C.I.z Safety, efficacy, pharmacovigilance changes

      Type IA (C.1.z) variation to update SmPC section 4.4, 4.8 and PIL section 2 and 4 to include adverse reactions with a frequency not known: myasthenia gravis and ocular myasthenia as per PRAC recommendations on signals adopted at the 9-12 January 2023.

      SmPC sections updated: 4.4, 4.8, 10.

    • Changes: (Updated: 27 Sep 2022)

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    • Changes: (Updated: 27 Sep 2022)

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    • Changes: (Updated: 27 Sep 2022)

      Unlinked from 20075

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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