PIL- Atorvastatin Film-coated Tablets (PL 20075/0488, 0489, 0490, 0491): Change history
View Patient Information Leaflet (PIL- Atorvastatin Film-coated Tablets (PL 20075/0488, 0489, 0490, 0491))
Last updated on this site: 03 Mar 2025
To update SmPC: sections 4.4, 4.5, 5.2 and PIL: section 2 in line with the reference product Lipitor.
PIL sections updated: Heading, 1, 2, 3, 4, 5 and 6.
Last updated on this site: 03 Mar 2025
To update SmPC: sections 4.4, 4.5, 5.2 and PIL: section 2 in line with the reference product Lipitor.
PIL sections updated: Heading, 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 03 Mar 2025)
To update SmPC: sections 4.4, 4.5, 5.2 and PIL: section 2 in line with the reference product Lipitor.
PIL sections updated: Heading, 1, 2, 3, 4, 5 and 6.
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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
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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.
PIL sections updated: 2, 4, 6.
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Changes: (Updated: 27 Sep 2022)
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Changes: (Updated: 27 Sep 2022)
Unlinked from 20075
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Changes: (Updated: 20 Sep 2022)
Initial upload