SmPC - Darunavir 600 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Darunavir 600 mg Film-coated Tablets)
Last updated on this site: 26 Feb 2024
Description of update: To update the SmPC and PIL of procedure DK/H/2709/001-006/DC, in accordance with the reference product Prezista, which is registered via the centralised procedure EMEA/H/C/000707, updated on 17 August 2022.
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.
Last updated on this site: 26 Feb 2024
Description of update: To update the SmPC and PIL of procedure DK/H/2709/001-006/DC, in accordance with the reference product Prezista, which is registered via the centralised procedure EMEA/H/C/000707, updated on 17 August 2022.
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.
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Changes: (Updated: 26 Feb 2024)
Description of update: To update the SmPC and PIL of procedure DK/H/2709/001-006/DC, in accordance with the reference product Prezista, which is registered via the centralised procedure EMEA/H/C/000707, updated on 17 August 2022.
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.
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Changes: (Updated: 30 Jan 2023)
Variation Description: To introduce a new pack size (180 tablets - 3 bottles x 60 tablets in a multipack) for Darunavir 600mg film-coated tablets - DK/H/2709/005/DC.
SmPC section(s) updated – 6.5, 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload