SmPC - Rosuvastatin 5mg, 10mg, 20mg, 40mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Rosuvastatin 5mg, 10mg, 20mg, 40mg Film-coated Tablets)
Last updated on this site: 31 Jul 2023
Description of update: The proposed change is: C.I.2. a) Update SmPC section 4.3 and 4.5 and PIL section 2 and 4 information in line with the information of Reference product (Crestor 5mg, 10mg, 20mg and 40mg filmcoated tablets. The date of approval is 27-July-2023.
SmPC sections affected: 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 10.
Last updated on this site: 31 Jul 2023
Description of update: The proposed change is: C.I.2. a) Update SmPC section 4.3 and 4.5 and PIL section 2 and 4 information in line with the information of Reference product (Crestor 5mg, 10mg, 20mg and 40mg filmcoated tablets. The date of approval is 27-July-2023.
SmPC sections affected: 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 10.
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Changes: (Updated: 31 Jul 2023)
Description of update: The proposed change is: C.I.2. a) Update SmPC section 4.3 and 4.5 and PIL section 2 and 4 information in line with the information of Reference product (Crestor 5mg, 10mg, 20mg and 40mg filmcoated tablets. The date of approval is 27-July-2023.
SmPC sections affected: 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 10.
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Changes: (Updated: 02 Jun 2023)
Description of update: To update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of the PL to implement the signal recommendation on 3-hydroxy 3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins).
SmPC sections updated: 4.4, 4.8, 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload