PIL- Atorvastatin Film-coated Tablets (20075/0488, 0489, 0490, 0491): Change history
View Patient Information Leaflet (PIL- Atorvastatin Film-coated Tablets (20075/0488, 0489, 0490, 0491))
Last updated on this site: 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.
Last updated on this site: 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: 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