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: 02 Oct 2025
The Federal Office for Safety in Health Care accepts all the changes detailed in your application (date of approval: 29.09.2025). The following changes were noted:
B.II.b.1.a Finished Product, manufacturing site,
Type IAIN (B.II.b.1.a) to add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.
B.II.b.2.c.2 Finished Product, manufacture, change batch release details or importer
Type IAIN (B.II.b.2.C.2) to add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
Last updated on this site: 02 Oct 2025
The Federal Office for Safety in Health Care accepts all the changes detailed in your application (date of approval: 29.09.2025). The following changes were noted:
B.II.b.1.a Finished Product, manufacturing site,
Type IAIN (B.II.b.1.a) to add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.
B.II.b.2.c.2 Finished Product, manufacture, change batch release details or importer
Type IAIN (B.II.b.2.C.2) to add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
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Changes: (Updated: 02 Oct 2025)
The Federal Office for Safety in Health Care accepts all the changes detailed in your application (date of approval: 29.09.2025). The following changes were noted:
B.II.b.1.a Finished Product, manufacturing site,
Type IAIN (B.II.b.1.a) to add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.
B.II.b.2.c.2 Finished Product, manufacture, change batch release details or importer
Type IAIN (B.II.b.2.C.2) to add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
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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