SmPC- Allopurinol 300mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Allopurinol 300mg Tablets)
Last updated on this site: 07 Dec 2023
Description of update: To update sections 4.2, 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC and the PIL in line with the reference product, Zyloric 100 mg, 300 mg tablets, PL 39699/0001, 0002, MAH: Aspen Pharma Trading Limited. Additionally, the excipient warning for lactose has been updated in line with the 2019 EC guidelines on excipients (EMA/CHMP/302620/2017). Furthermore, additional updates have been made to align the PIL with the SmPC and update in line with the latest QRD template. An editorial change has been made to section 3 of the SmPC for Allopurinol 300mg Tablets to correct a spelling mistake.
SmPC Sections updated: 3 (300mg only), 4.2, 4.4, 4.5, 4.6, 4.8, 5.2 and 10.
Last updated on this site: 07 Dec 2023
Description of update: To update sections 4.2, 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC and the PIL in line with the reference product, Zyloric 100 mg, 300 mg tablets, PL 39699/0001, 0002, MAH: Aspen Pharma Trading Limited. Additionally, the excipient warning for lactose has been updated in line with the 2019 EC guidelines on excipients (EMA/CHMP/302620/2017). Furthermore, additional updates have been made to align the PIL with the SmPC and update in line with the latest QRD template. An editorial change has been made to section 3 of the SmPC for Allopurinol 300mg Tablets to correct a spelling mistake.
SmPC Sections updated: 3 (300mg only), 4.2, 4.4, 4.5, 4.6, 4.8, 5.2 and 10.
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Changes: (Updated: 07 Dec 2023)
Description of update: To update sections 4.2, 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC and the PIL in line with the reference product, Zyloric 100 mg, 300 mg tablets, PL 39699/0001, 0002, MAH: Aspen Pharma Trading Limited. Additionally, the excipient warning for lactose has been updated in line with the 2019 EC guidelines on excipients (EMA/CHMP/302620/2017). Furthermore, additional updates have been made to align the PIL with the SmPC and update in line with the latest QRD template. An editorial change has been made to section 3 of the SmPC for Allopurinol 300mg Tablets to correct a spelling mistake.
SmPC Sections updated: 3 (300mg only), 4.2, 4.4, 4.5, 4.6, 4.8, 5.2 and 10.
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Changes: (Updated: 20 Sep 2022)
initial upload