PIL - Lansoprazole 15mg, 30mg Gastro-resistant Capsules: Change history
View Patient Information Leaflet (PIL - Lansoprazole 15mg, 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.
PIL sections updated: 2, 4 and 6.
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.
PIL sections updated: 2, 4 and 6.
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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.
PIL sections updated: 2, 4 and 6.
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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.
PIL sections updated – 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 07 Jun 2023)
Amendment to wording in section 2: Warnings and Precautions.
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Changes: (Updated: 27 Feb 2023)
Variation Description: To register at the request of the MHRA to update leaflet warning for lansoprazole - Section 2 -reduced vitamin B12 absorption.
PIL section(s) updated – 2 & 6.
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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).
PIL sections updated – 2 and 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload