SmPC - Lansoprazole 30mg Gastro-resistant Capsules: Change history
View Summary of Product Characteristics (SmPC - Lansoprazole 30mg Gastro-resistant Capsules)
Last updated on this site: 25 Jan 2024
Description of update: To update section 4.4 and 4.8 of the SmPC in line with reference product, Zoton FasTab 15 mg, 30 mg oro-dispersible tablets (PL00057/1296, 1297 MAH: Pfizer Limited Dated 01/09/2023). The PIL has been updated accordingly.
SmPC Sections updated: 4.4, 4.8 and 10.
Last updated on this site: 25 Jan 2024
Description of update: To update section 4.4 and 4.8 of the SmPC in line with reference product, Zoton FasTab 15 mg, 30 mg oro-dispersible tablets (PL00057/1296, 1297 MAH: Pfizer Limited Dated 01/09/2023). The PIL has been updated accordingly.
SmPC Sections updated: 4.4, 4.8 and 10.
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Changes: (Updated: 25 Jan 2024)
Description of update: To update section 4.4 and 4.8 of the SmPC in line with reference product, Zoton FasTab 15 mg, 30 mg oro-dispersible tablets (PL00057/1296, 1297 MAH: Pfizer Limited Dated 01/09/2023). The PIL has been updated accordingly.
SmPC Sections updated: 4.4, 4.8 and 10.
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Changes: (Updated: 21 Jul 2023)
Variation Description: To update SmPC sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.3 to align with the Reference product following comparison with Zoton FasTab 15, 30 mg oro-dispersible tablets, PL 00057/1296, 1297 (MAH: Pfizer Limited, dated 11/2022). Consequential updates made to the PIL.
SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.8, 5.3 and 10.
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Changes: (Updated: 23 Feb 2023)
Variation Description: To update sections 4.4, and 4.8 of the SPC and section 2 of the leaflet in line with PRAC recommendations (PSUSA/00001827/202112) for tubulointerstitial nephritis (TIN).
SmPC sections updated – 4.4, 4.8 and 10.
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Changes: (Updated: 06 Dec 2022)
To update sections 4.4, 4.8 and 5.3 of the SmPC in line with reference product Zoton FasTab* 15 mg oro-dispersible tablets.
The PIL has not been updated.
SmPC sections updated – 4.4, 4.8, 5.3 (15mg only) and 10
No update to artwork
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Changes: (Updated: 20 Sep 2022)
Initial upload