SmPC - Loratadine 10mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Loratadine 10mg Tablets)
Last updated on this site: 01 Aug 2023
Website administration update only- no changes to file
Last updated on this site: 01 Aug 2023
Website administration update only- no changes to file
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Changes: (Updated: 01 Aug 2023)
Website administration update only- no changes to file
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Changes: (Updated: 27 Jul 2023)
Section 4.2 of the SmPC has been updated in line with the reference product, Clarityn Allergy 10mg Tablets- PL 00012/0657 (MAH: Bayer PLC) to remove the wording ‘and for children weighing 30kg or less, 5ml (5mg) every other day is recommended’
Additionally SmPC section 4.4 has been updated in line with the EC guidelines on Excipients (EMA/CHMP/302620/2017) for lactose, consequently PIL section 2 has been updated.
The storage conditions in PIL section 6 have been updated to align with SmPC section 6.4.
The PIL has been updated throughout to align with the latest QRD template (Version 10.2, 02/2021) as well as the correction of grammar and spelling.
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Changes: (Updated: 21 Sep 2022)
Initial upload